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OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.
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With the implementation of the "BRAIN initiative" in various countries, neuroethical governance has become an important concern of the international community. After ten years of development, the "BRAIN initiative" in the United States has formed a relatively complete ethical governance system. By interpreting the strategic report of the "BRAIN initiative" in the United States, analyzing its basic framework of ethical governance, dissecting its governance practice mechanism, and conducting research from the aspects of top-level design and construction, regulatory model innovation, promoting public participation, enhancing international dialogue, and improving soft and hard regulations, this paper provided some reference and thoughts for the ethical governance of the "BRAIN initiative" in China.
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Serious hazards of transfusion(SHOT)in the United Kingdom has been received reporting of the adverse events of delayed transfusion for more than ten years. Hemovigilance Module Surveillance Protocol in Biovigilance Component in National Healthcare Safety Network in the United States updated the incident codes to include under-transfusion with the creation of a new process code: no blood (NB) and four incident codes in October 2022. This review introduces the monitoring practice of delayed transfusion/under-transfusion in the UK and the USA, makes a suggestion to incorporate delayed transfusion/under-transfusion due to blood shortage into the national health standard on the classification of transfusion reactions and haemovigilance protocol in China, and to do a national survey as well, therefore the real world data and evidences would be obtained and used for further policy making.
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Objective:This paper focused on the research of the appointment system in interdisciplinary research institutions of world-class universities in China and the United States. The positive effects of different employment and evaluation systems as well as existing problems were sorted out and analyzed, and some suggestions were put forward to optimize and innovate the teacher appointment system and promote the interdisciplinary construction of Chinese universities.Methods:This paper focused on the new teacher appointment system adopted by representative universities in China and the United States to promote the development of interdisciplinary research and used the methods of literature research, questionnaire survey, case analysis, and in-depth interview to sort out and analyze the different systems.Results:Based on the broad perspective of the ″new concept-(artificial) selection-stabilization″ system change, the implementation of an interdisciplinary joint appointment in our country has experienced a stage of ″new concept generation″ at present, but it is still in the stage of ″institution establishment and stabilization″. The personnel management system for teachers engaged in interdisciplinary research still needs to be improved, and there are still outstanding problems in the areas of evaluation and promotion pressure, financial resources guarantee, teachers′ sense of belonging, administrative costs, etc.Conclusions:Referring to the advanced experience at home and abroad, Chinese universities should focus on breaking the barriers of distributing the interests of results, improving interdisciplinary talent evaluation mechanisms, adopting a variety of flexible appointment systems depending on demands, and building a benign flow ecology of interdisciplinary human resources. Apart from these, urgent attention should be paid to improving the administrative work system and interdisciplinary cultural system construction.
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Objective:The development level of health science technology innovation plays crucial role in the sustainable development of economy and society in China. This article summarizes the experience of U. S., compares with the status quo of health science technology innovation in China, to provide possible reference for the future development in this field.Methods:This study mainly uses literature review, comparative reference and other methods to analyze the health science technology innovation and its development experience in U. S.Results:The U. S. has formed a health science and technology system with state-level research institutions as the main component, and has a strategic layout in the frontiers of basic medicine, key diseases, key population health, and medical device technology.Conclusions:Based on the experience of the u. s., China should establish a continuous medical research investment mechanism, strengthen the sharing of basic resources, attach importance to deployment in key areas, and continue to support cutting-edge research.
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OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.
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OBJECTIVE：To provi de reference for drug admini stration supervision of biosimilars in China. METHODS ： Referring to the authoritative documents of the official websites of National Medical Products Administration of China ，FDA of the United States ，European Drug A dministration and Japan ’s D rug and M edical Devices Agency ，and comparing their regulatory measures on the definition ，effectiveness，safety and clinical application of biosimilars，the suggestions were put forward for the improvement of regulatory measures of biosimilars in China. RESULTS & CONCLUSIONS ：Although the definitions biosimilars in different countries/regions were different ，they all required that biosimilars should have the same drug quality ，safety and effectiveness as their corresponding reference drugs. The United States ，the European Union and Japan required enterprises to provide studies on the similarity of early pharmacy ，non-clinical studies such as pharmacology and toxicology ，and clinical studies on immunogenicity ，pharmacokinetics and pharmacodynamics of biosimilars and reference drugs. However ，the similarity between biosimilars and reference drugs had not been required in China. All countries/regions supported the extrapolation of indications of biosimilars. Among which the United States and the European Union required manufacturers to provide detailed data ；Japan only mentioned the relevant concepts of indications extrapolation of biosimilars，but did not mention the specific data requirements. The relevant description of the conditions for the extrapolation of biosimilars in China was not clear enough ，and its application in China was still facing great challenges. In terms of drug interchangeability ，although the United States allowed the use of interchangeable biosimilars to replace reference drugs under the conditions permitted by state laws ，no relevant biosimilars had been approved；European countries had different regulations on the interchangeability of biosimilars；but there was no document explicitly mentioned in China and Japan on the interchangeability of biosimilars. It is suggested that the principle of comparison should be further improved and strict requirements should be appropriately enforced in ensuring the effectiveness and safety of biosimilars；in the field of indication extrapolation ，more detailed data requirements should be put forward ，and the possible risks after extrapolation should be evaluated scientifically ；in terms of the interchangeability of biosimilars ，it is suggested to try to implement the principle of conversion of biosimilars ，but it should be used after consultation among doctors ，pharmacists and patients，and drug use safety should be monitored timely. Meanwhile ，a sound traceability system should be established to ensure drug safety of patients.
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OBJECTIVE：To provide referen ce for improving commission management system of medical insurance in China. METHODS：By analyzing the problems of commission management system of medical insurance in China ，studying the specific types，responsibility division and its features of basic medical insurance contractors in the United States ，the suggestions were put forward for improving corresponding system in China. RESULTS & CONCLUSIONS ：There are some problems in the entrusted management of medical insurance in China ，including that the fair competition mechanism has not been established ；the operation and management of social security fund lacks of supervision mechanism ；the role of the government is unclear and inexperienced ； the imperfect supervision mechanism causes follow-up problems ；it is still uncertain whether the entrusted management system can improve the efficency of medical insurance management. In the United States ，the way of entrusted management of medical insurance was to introduce the third-party management. The contractors employed by the Centers for Medicare and Medicaid Services in the United States mainly included medical insurance contractor ，zone program integrity contractor ，comprehensive error rate test review contractor and statistical contractor ，supplemental medical review contractor ，qualified independent contractor and so on ，among which medical insurance contractor was in the core position. Each contractor had a clear division of labor in handling medical claims ，preventing medical fraud ，reviewing the correctness of payments ，evaluating medical records and handling appeals. This mode greatly reduced the work pressure of the government ，improved the efficiency of medical insurance management and operation，and promoted the continuous improvement of the whole system. It is suggested that China should expand the scope of social agency management ，clarify the responsibilities of government and social resources ，introduce various types of social economic organizations and establish a complete and effective performance supervision and management system in order to improve the modernization level of China ’s medical insurance governance.
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@#Objective To compare the current status of clinical studies regarding lung cancer between China and the United States in 2019, and to indicate the weakness, trend and future development direction of clinical studies drug treatment in China. Methods The data of lung cancer clinical studies from January 1st to November 30th, 2019 in China and the United States were retrieved and analyzed through Informa pharmaprojects database. Results The United States was superior on the number of projects (128 vs. 156) and research institutions (743 vs. 2 250). Compared with the United State, there were more phase Ⅲ confirmatory researches (19.5% vs. 10.3%), bioequivalent drug researches (3.1% vs. 0%), and researches initiated by academic institutions (39.8% vs. 28.1%) in China. The United States exhibited advantages in phaseⅠ andⅠ/Ⅱstudies (25.8% vs. 60.3%), immunodrugs (49.2% vs. 60.3%), primary tested drug ratio (61.7% vs. 93.6%), targets abundance (32.9% vs. 69.6%), and chimeric antigen receptor-T (CAR-T, 0.7% vs. 7.1%). Conclusion Compared with the United States, China should pay more attention to innovative drug investigations in early phase of clinical studies, especially novel immune agents, vaccines, and CAR-T.
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OBJECTIVE：To provide applicable suggestions for exploring the establishement of the vaccination rare adverse reactions compensation fund in China. METHODS ：Through literature research and regulation review ， the establishment background，compensation principle ，management and operation mode （including management methods ，source，uses and risk control measures）of Vaccine Injury Compensation Trust Fund in the United States were introduced in details ，while the operation effect was evaluated ，and the suggestions for the establishment of the vaccination rare adverse reactions compensation fund in China were put forward. RESULTS & CONCLUSIONS ：The U.S. National Vaccine Injury Compensation Program （VICP）imposed a certain proportion of vaccine excise tax on each dose of vaccine sold by vaccine companies ，and established the Vaccine Injury Compensation T rust F und as its fixed source of compensation funds to provide compensation for vaccine victims. The fund belonged to the special needs trust. When the vaccine victims met the compensation conditions ，they can convert their compensation rights into the beneficial rights under the trust law. The fund was managed by the Fund Management Branch under U.S. Dept. of the Treasury，and it took a variety of risk control measures such as capital guaranteed investment ，subrogation，emergency preparedness. As of 2018，a large number of fund balances had been accumulated ，which was sufficient to ensure the solvency of VICP. It is suggested that China fully learn from the successful experience of the Vaccine Injury Compensation Trust Tund of the United States ， based on the domestic reality ，start from improving the relevant legislation of the compensation fund ，building the compensation management system ，making clear the source and usage of the fund ，taking various risk control measures ，so as to explore the establishment of China ’s vaccination rare adverse reactions compensation fund ，further expand the financing channels ，stabilize the source of funds ，and improve the compensation effect.
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The optometrist education system in the United States has a history of more than 100 years and has become a complete and mature system. It contains five parts: optometry admission test (OAT); a complete curriculum of optometry, including basic medical lectures, optometric theories and skills, large amount of clinical practices; the National Board Exam of Optometry (NBEO) which is mandatory for every licensed optometrist/practitioner, a one-year optional resident program; continue education in every year for renewing optometric licenses. We analyzed differents such as the enrollment requirements, the training time, the graduation requirements and the career perspective of the optometry education system between China and the United States were analyzed, we want to develop a optometrist training system with Chinese characteristics.
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The optometrist education system in the United States has a history of more than 100 years and has become a complete and mature system . It contains five parts: optometry admission test (OAT);a complete curriculum of optometry, including basic medical lectures, optometric theories and skills, large amount of clinical practices; the National Board Exam of Optometry (NBEO) which is mandatory for every licensed optometrist/practitioner, a one-year optional resident program; continue education in every year for renewing optometric licenses. We analyzed differents such as the enrollment requirements, the training time, the graduation requirements and the career perspective of the optometry education system between China and the United States were analyzed , we want to develop a optometrist training system with Chinese characteristics.
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The United States attaches importance to teachers' teaching ability development in higher medical colleges and universities. The measures include integrating the promotion of teacher development into the certification standards of colleges and universities, establishing a specialized service organization, updating the training content and form , and evaluating the effectiveness of the training programs . The enlightenment for medical colleges and universities in China is to improve the status of teaching in colleges and universities, strengthen the construction of teaching service organization, scientifically plan the teachers' career development, enrich the teacher training content, and diversify the training model.
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By analyzing the training of resident doctors in the University of Maryland Shock Trauma, this paper compared the similarities and differences of standardized resident training between China and the United States in policy, training base, selection of teaching teachers, selection of training objects, assessment methods and financial subsidies to the students. It can be concluded that standardized resident training of orthopedics in the United States is more purposeful and systematic and pays more attention to the connection between knowledge and clinical practice, skills and operation, and the cultivation of the ability to deal with patients independently. The training of orthopedics residents in the United States began earlier and had more experience than China, which can be an example for the standardized training of orthopedics residents in China.
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With the rapid development of Internet, the number of online medical service review websites has gradually increased, whereby more and more patients use those engines to share their experience in health treatment, discuss the quality of medical services or rate physicians, and make more researches on medical institutions and doc-tors just to detailed information on the remedies of their health cases. This paper selected the UK and US as typical cases of countries that have rapidly developed in this field, and focused on UK’s NHS Choices and the United States’ RateMDs, Healthgrades and Yelp websites. Their current status, organization structure, content, characteristics, ex-perience and problems were analyzed and summarized. At present, China’s medical service online review is still in the ascendant, but the relevant policies and academic research are facing scarcity. Based on the situation in China and the experience from the UK and US, this paper proposed policy suggestions as follows: (1) Establishing a na-tional comprehensive medical service platform led by the government or professional and competent association which integrates health information query, retrieval and medical service review functions. (2) Set up a scientific and pro-fessional organization structure for standardized and orderly governance. (3) Combining the subjective reviews with objective quality indicators. (4) Adopting performance evaluation, and so on. All of these concerns are proposed in order to improve the medical service transparency and responsiveness, and to promote the medical service quality im-provement.
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Reflective capacity is a very important tool of assessment for health professionals. Re-flective writing (RW) curriculum, aiming at promoting reflective capacity, is proliferating within American medical education. This paper generalizes the training process of RW capacity, its contents and evaluation tool. It discusses the meaningfulness of RW curriculum in improving doctor-patient relationship and profes-sionalism and developing academic goals. For better practice, the paper makes suggestions that we should reform our traditional medical education, develop interdisciplinary teams of teachers and evaluation tool and incorporate RW curriculum into continuing medical education.
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By means of literature review and comparative study, the paper studied the organization and policy system of emergency drug administration in the U.S. As found by the authors, that the U.S. has established a horizontal and vertical organizational structure system centering on the Department of Health and Human Services. This system covers a series of policy and legal regulations, such as the research and development, procurement, storage, emergency use, and clinical treatment of emergency medical products. In consideration of the experience of emergency drug administration in the U.S. and problems existing in China's current system in command and management, departmental coordination, resource allocation, and legal system construction of emergency drug, it is suggested that China should establish a core organization for emergency drug command and management, and improve relevant legal system. China also needs to focus on enhancing capabilities of local medical emergency rescue and information transmission, in order to establish a coordinated, well-organized, resource-sharing system of drug emergency administration in the country.
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Information disclosure is important for the government and society to monitor the fulfillment of social responsibility of hospitals. This paper introduced the existing legislatures of the community benefits information disclosure system for non-profit hospitals in the United States, and analyzed the "two-level and two-way reporting system" of these hospitals, based on facts of California, Illinois and other regions. In the end, the authors put forward inspirations for the development of public hospitals' community benefits system in China as follows. This refers to the establishment of a social responsibility reporting system,stipulating the hospital and its health authority as the entities accountable for disclosure;a two-level/two-way reporting mechanism to improve the integrity of information disclosure;and standardization of information disclosure content and better timeliness and accessibility of information disclosure.
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This paper introduced the legislative development of community benefits system of nonprofit hospitals at federal level in the United States,as well as state legislatures in this regard. Based on America's experiences, an analysis was made on the "community benefits and health promotion model", which refers to community health needs assessment, health promotion programs, program implementation, supervision and appraisal. Thus the authors put forward inspirations for the social responsibility system development of public hospitals in China as follows. This refers to the establishment of hospitals' social responsibility system; development of community health promotion planning based on health needs;and establishment of social responsibility information disclosure system for fulfillment of their social responsibilities.
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The establishment of a scientific and reasonable medical service price dynamic adjustment mechanism is the focus of the current reform of public hospitals in China.This paper analyzed the medical service price reform history in the United States, the price dynamic adjustment of the main body and its process, as well as the development trend of medical service price reform.At the same time, the existing problems of medical service price adjustment in China were briefly analyzed, and put forward 1) the establishment of multi-participant dynamic adjustment model;2) the establishment of the medical service standard value system, strengthening Medicare payment standard construction;3) and gradually changing the current fee-for-service payment system and establishing DRGs and performance based payment mechanism and other policy recommendations.