Framework design of WHO and typical national essential medicine lists and its implications for China / 中国药房

OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.

Research on the operation mechanism of clinical research network in typical international countries / 中华医学科研管理杂志

Objective To summarize the experience of the clinical research network operation mechanism in typical countries,and provide reference for the construction of China's national clinical research network.Methods Literature research method and the inductive analysis method were used to analyze the information on official website and literature materials of the clinical research network in typical countries to summarize their characteristics and experience.Results The clinical research network in typical countries had developed an optimized and efficient operational mechanism,including the development of information platforms,development of tools and templates,streamlined review processes,implementation of membership systems,establishment of sharing mechanisms,and complementary models of clinical centers and research institutes,stable sources of funds,establishing reward and punishment mechanisms,etc.Conclusions China's national clinical research network is still at the initial stage,government should make full use of the information platform,strengthen human resource input,and accelerate the research and exploration of more innovative management mechanisms.

Study on national health planning of several typical countries based on content analysis method / 中国卫生政策研究

@#Objective: To analyzethe hot areas and trends of current health planning policies around the world based on content analysis method, andreveal the differences in contents of the planning between countries, so as to provide reference for health planning and health development direction. Methods: Based on the WHO Country Planning Cycle Database, 15 Planning documents were chosen, from whichkeywords were screened, and thedegree centralitywas calculatedusing UCINET 6. Results: Keywords of planning documents couldbe classified into six analytical dimensions including fundamental philosophy, system and mechanism, health resources, health services, health-related factors and effect appraisal. High frequency keywords in documents of countries with different levels of development wereboth similar and different ； whereby thedegree centrality of the basic concept and service dimension was found to be relatively high in developed countries, while the degree centrality of keywords of health-related factors andhealth resources dimension washigher in developing countries. Conclusions: The concept of “health” and integration M has always got moreattention from all countries. Health planning in developed countries tends to focusmore about substance and basic beliefs, with an emphasis on evidence-based policy-making. However, in developing countries,more attention is paid to cooperation, ensuring the provision of health services through input and rational allocation of health resources, and reducing the burden of diseases. Even though China has some characteristics of developed countries, its health planning mainly reflects the characteristics of developing countries. It is suggested that more attention should be paid to evidence-based support, a more integrated medical and health system should be built, and attention should be given to the evaluation and feedback of the health planning policies.

International experiences and implications for education and training of health professionals in rural areas / 中国卫生政策研究

Objectives:To describe and summarize international evidences on policies and programs for training health personnel in rural areas,to identify best practice to increase health manpower in rural areas, and to provide references for China's policy of targeted admission program. Methods:This is a literature review based research. 48 literatures in Chinese and English were selected about the training of health professionals in rural areas at home and a-broad. Thematic framework approach was applied to review and analyze the related strategies and practices,and les-sons learned. Results: Common measures to train health personnel in rural areas included: enrollment of students with a rural background,tutoring system in medical training,internship in rural health institutions, financial incen-tives,and compulsory rural services after graduation. Lessons learnt:(1) adequate financial resources are a prereq-uisite for smooth program implementation;(2) Good project management and evaluation are critical aspects of effec-tive project implementation;(3) choosing the right combination of various practices to implement such projects can improve effectiveness. Conclusions:The policy of targeted admission program is suitable for China's current situation. Meanwhile,international experiences can provide valuable lessons to improve China's program design and implemen-tation and these include:increasing capital investment,strengthening management and evaluation,and strengthening sector cooperation to further improve targeted admission program.

Anti-medical violence legislation: international experience and inspirations for China / 中华医院管理杂志

Traditional mindset in anti-medical violence legislation tends to divert the responsibility to prevent medical violence to the party of the lowest costs, a design of obvious loopholes in reducing medical violence occurrence. By combining the legal liability and penalty adjustment to counter medical violence crimes, the US, Australia and South Korea are trying to match the private cost of victims and its social cost with the punishment of crime law. In this sense, China should highlight the nature of public safety of medical service, zero tolerance report and optimal punishment to medical violence crimes. This approach can take place of the existing incentive mechanism featuring violent conflicts, being conducive to building a safe and harmonious doctor-patient relationship.

International experience research on biobank sharing / 中华医学科研管理杂志

Objective Successful experience of biobank sharing in several developed countries or areas are analyzed to provide some reference for China.Methods This article reviews the sharing measures of biobanks in some developed countries or areas,such as United States,European Union countries,and summaries their successful experience on organization structure,operating mechanism and corresponding service.Results Based on their own characteristics,suitable sharing organizational structunes,unified standards and pubilc information platforms have been established in these developed countries.They kept improving the sharing rules and processes,as well as corresponding service.Conclusions As to the problems of biobank sharing in China,we suggest that we should establish the system of resources sharing,make standards of biobank building,promote the standardization of the existing biobanks,construct the national information platform and formulate favorable polices for biobank sharing.

Experience of Quality Supervision of Pharmaceutical Production in International Clinical Trial / 中国药师

Objective:To put forward relevant policy recommendations for strengthening the quality control of clinical trial drug production in China. Methods:The objective differences of clinical trials and marketing drugs in the production and management as-pects were in-depth analyzed, and the lessons in clinical trial drug production quality supervision and management experience were drawn from the FDA and the European Union EMA. Results and Conclusion:Based on the particularity of clinical trial drug produc-tion management,it is suggested to formulate the administrative rules and technical standards for the quality control of clinical trial drug production and amend relevant laws and regulations timely so as to achieve the purpose of strengthening the quality supervision of drug production in clinical trials.

Study on the Path of Promoting Social Responsibility of Pharmaceutical Corporate in China / 中国药房

OBJECTIVE:To provide reference for strengthening the supervision and management of responsibility of pharmaceutical corporates in China.METHODS:The status quo of social responsibility of pharmaceutical corporates in China were analyzed,and international experience of the United States,European countries and so on were analyzed.The ways to enhance the social responsibility of pharmaceutical corporates in China were proposed.RESULTS & CONCLUSIONS:Since the corporate social responsibility was first written into the People's Republic of China Company Law in 2005,the Chinese government has attached great importance to the implement of corporate social responsibility;however,the social responsibility of pharmaceutical corporates in China is still in the initial stage and lags behind other industries.The United States promotes corporate social responsibility through the formulation of perfect medical policies and regulations,non-governmental organizations participating in supervision,and the establishment of a sound financial incentive mechanism;Government in Germany,Britain and other European countries play an important role in promoting corporate social responsibility;at the same time,perfect supervision system of civil society is an important driving force to promote corporate social responsibility.When promoting the social responsibility of pharmaceutical corporates in China,it is necessary to improve the awareness of social responsibility of pharmaceutical enterprises through multiple paths,such as giving full play the supervision and management role of government,strengthening public supervision and management function,strengthening the system construction of social financial responsibility,improving the awareness of responsibility of pharmaceutical corporates.

"Study and Enlightenment on""Separation of Prescribing and Dispensing""in China Based on International Experiences" / 中国药房

OBJECTIVE:To provide reference for further promoting the implementation ofseparation of prescribing and dis-pensingpolicy which fit China's national conditions. METHODS:Based on literature review,informant interview,and filed in-vestigation the development ofseparation of prescribing and dispensingwere compared between typical eastern and western coun-tries. Constraints ofseparation of prescribing and dispensingin China were explored,international successful experiences were summarized to inspire appropriate implementation of this policy in China. RESULTS & CONCLUSIONS:There are four con-straints in the implementation ofseparation of prescribing and dispensingin China. Firstly,the legal foundation is yet established for the professional development of pharmacists. Secondly,the medicine pricing and hospital financing systems are unreasonable. Thirdly,patients'ownership of prescriptions and right of dispensing options are monopolized by hospitals. Fourthly,safety of medi-cines use is yet ensured.Separation of prescribing and dispensingshould follow the rules of social and economic development and should be adjusted to adapt local conditions.Separation of prescribing and dispensingpolicy itself may not help to achieve the objectives of cost containment and rational use of medicines. To achieve the intended objectives,legislation of Pharmacist Law should also be accelerated to clearly define the role of pharmacist and guide the behavior of prescribers with economic levers.

International Experiences of Response to Medicines Shortage and the Implications to China / 中国药房

OBJECTIVE:To propose policy recommendations for China to solve medicines shortage fundamentally. METH-ODS:The causes of medicines shortage in China were analyzed. Chinese,American,Canadian and European literatures and the government website of typical countries about responses to medicines shortage since 2010 were searched and reviewed. RESULTS& CONCLUSIONS:Medicines shortage in China are due to regulation and policy changes and unfair competition. Both China and foreign countries face the problem of medicines shortage to some extent,either due to demand side or supply side. It is necessary to improve related laws and regulations to deal with medicines shortage,establish multi coordinative mechanism,shortage monitor-ing system and information and communication network platform with the patient-centered approach,leave reasonable profit for pharmaceutical production and distribution enterprises and crack down hoarding of raw materials. The experiences of typical coun-tries in defining clear responsibility for each stakeholder in the medicines supply chain,establishing comprehensive policies and co-ordinative mechanisms in response to medicines shortage are valuable for China to follow.

Implications of International Experience for Building China's Long-term Care Insurance System / 中国卫生经济

Objective:To introduce several international long-term care insurance systems so as to provide references for building China's long-term care insurance system.Methods:Literature of International long-term care insurance system were reviewed to extract and summarize the content so as to provide suggestion and references for China's system construction.Results:It concluded 4 modes of systems for long-term care insurance including the private long-term care social insurance like Netherlands,the public long-term care social insurance like German and Japan,long-term care commercial insurance like America and national long-term care insurance like England.The advantages of different modes could be learned to form Chinese system.Conclusion:The long-term care insurance systems of Netherlands,German,Japan,American could be learned for our system construction,but they also had disadvantages.Therefore,on the basis of the foster strengths and circumvent weaknesses,the reasonable long-term care insurance system was formed.

International Experience of Chronic Disease Management and Enlightenment / 中国药房

OBJECTIVE:To provide reference for comprehensive intervention and management of chronic disease in China.METHODS:The global chronic disease trends and disease burden were summarized;theoretical framework,practice and experience of international chronic disease management were summarized and analyzed as well as enlightenment on domestic chronic disease management.RESULTS&CONCLUSIONS:Worldwide prepresentative chronic disease theory model mainly involved USA chronic disease nursing model and WHO innovation care for chronic conditions.Main experience of international chronic disease management is that managing based on community,confirming preferential intervened disease types,adopting standardized clinical diagnosis and treatment pathway,designing rational transfer treatment system,providing patient self-management support.At pres ent,chronic disease management have been improved in China,but is still poor in community management.It is necessary to strengthen community medical staff training about chronic disease prevention and treatment and health education for social group.

"The Construction Strategy of a decision - making transformation system in China's Health Technology Assessment: A typical international experience based on the ""3-phase"" analysis model for the health technology assessment decision-making transformation" / 中国卫生政策研究

International experiences have proved that a smooth health technology assessment ( HTA) decision-making transformation played a key role in maintaining a sustainable health system. Based on the knowledge/decision transformation theory, this paper proposed a novel framework for the analysis of HTA decision transformation models. The framework is the three-stage analysis which includes four stages of pre-cognitive preparation, core decision-making transformation and final results implementation, respectively. Using this analytical framework, this paper ana-lyzed and summarized the empirical experiences of HTA decision transformation in three typical countries including the United States, United Kingdom and Germany. Finally some policy recommendations and relevant concrete meas-ures were proposed to promote the construction of an HTA decision-making transformation system in China.

Preliminary Discussionon the Legal Regulation of Internet Drug Operation / 中国医学伦理学

The legal regulation of Internet drugs in China is facing the dilemmas including that the legal authority is insufficient,the situation of drug safety is not optimistic,the mechanism of legal regulation lags behind,legal regulation content is inadequate and consumers lack trust in the purchase of online drug.Learning from the experience of internet drug regulation in the United States and Britain,our country could seek the rules of law for improving internet drug regulation.It includes establishing and gradually perfecting the regulation system of internet drug,establishing the associative mechanism of relative departments,strengthening the daily supervision,fully guaranteeing the legitimate interests of consumers and clearing the legal responsibilities of licensed pharmacists.

Medical insurance anti-fraud mechanism from the perspective of cooperative governance: In-ternational experience and implications / 中国卫生政策研究

With the rapid development of China's social insurance,the phenomenon of medical insurance fraud is also increasing,which seriously threatens the comprehensive operation of health insurance funds and medical insur-ance system. Because of the cooperation between the government and the market,Europe & US have accumulated a lot of experience and achieved considerable success in anti-medical fraud as the"harder-hit area"in insurance fraud. This paper discusses the anti-fraud mechanism of foreign medical insurance to establish medical anti-fraud agencies within the government,and give full play to the complementary role of non-profit organizations to strengthen the con-trol and supervision of medical insurance and health care institutions and uses modern information technology to im-prove anti-fraud level.

International Experiences of Medicines Insurance Payment Pricing Mechanisms and the Implications to China / 中国药房

OBJECTIVE:To provide reference for setting reasonable medicines insurance payment price in China.METHODS:We retrieved and analyzed academic articles formally published at home and abroad,official websites and government documents,summarized.medicines insurance payment pricing mechanism as well as fair solutions to high-cost medicines,so as to put forward the suggestions to formulate reasonable medicines pricing policy in China.RESULTS&CONCLUSIONS:The international medicines payment prices are usually determined by internal reference pricing method,incremental cost-effectiveness evaluation method and external reference pricing method.The sustainable and fair accessibility of high-cost medicines are promoted by fair medicines pricing program,medicines patent pool,open source medicines discovery znitiative and so on.After the goal of universal health care has been achieved in china,reasonable medical insurance payment price should be explored and formulated.It is necessary to adopt,intemal reference pricing method to determine the payment standard of completitive eneric products,external reference pricing method or incremental cost-effectiveness evaluation method to determine the reference price for price negotiation of the innovative patented medicines;the concept of fair pricing for high-cost medicines.

Analysis of the high value medical consumables procurement in foreign countries and its inspi-ration to China / 中国卫生政策研究

The main intention of this paper is to propose suggestions for optimizing China 's high-value medical consumables centralized procurement .In this paper , we have analyzed the developed countries 'best practices in high-value medical consumables procurement from the perspectives of procurement principle ( s), key procurement bodies, procurement patterns, supervision, and management.The results of our analysis show that “Value for mon-ey” is the core principle in procurement and hospital route , national/regional centralized route ( s) , and group pur-chase organization ( GPO) route are four primary procurement patterns in foreign countries .Procurement management is optimized through improving product coding system and encouraging health technology assessment ( HTA) and clin-ical practitioners'involvement in procurement decision-making.In that perspective, it's been suggested that China's high-value medical consumables centralized procurement could be improved from three aspects:referring partial HTA indicators so as to enhance tender evaluation and realize value-based purchasing;establishing a standard and unified coding system for medical devices;introducing GPO route and make market surveillance mechanism into full play .

Community-based chronic disease interventions：Experience from the North Carolina Project in Finland and its implications for China / 中国卫生政策研究

Chronic Diseases have been the major public health problem since 1990 in China.This paper aims to explore the main results of the comprehensive sort of the North Carolina Project in Finland including the effects , key initiatives , intervention practices and successful experiences , and discusses the implications of Fanland experi-ence-based for the Chinese chronic disease intervention .The North Carolina Project shows that community-based in-terventions form an effective strategy for the prevention and control of chronic diseases .In order to respond effectively to the chronic disease challenges , the Chinese government should not only use community-based intervention strate-gies, but also implement a “comprehensive health policy”, creating a good and social atmosphere for the chronic dis-ease intervention .

Experience of health service system planning in some countries and its implications for China / 中国卫生政策研究

This paper reviews practices and features of health service system planning in some countries, and analyze its implications for China’s system planning. It is an international common practice to perform health service system planning to improve resource allocation efficiency, to meet multilevel demands of medical services, and to control dramatic growth of medical expenditures. Governments and their affiliated departments are the main body to formulate and implement the plans, and different levels of governments have different responsibilities in planning. During the procedure of formulating and implementing plans, collaborative governance network can be utilized to en-courage multi-party stakeholders to participate. The government should play an active role in planning to ensure the equity and accessibility of health services. The authority of planning can be achieved mainly through the comprehen-sive measures in legislation, political regulation, economic incentives, etc. Improved tools and methods based on multidisciplinary theories can be used to improve plan’s scientificity and delicacy. China can learn from international experience in formulating and implementing health service system plans.