OBJECTIVE: To provide proposal for government on dealing with the relationship between commercial and social property of drugs.METHODS: Multi-stakeholders subjects and their interrelation in the listing decision of drugs were investigated using game model.RESULTS & CONCLUSIONS: Innovation level of pharmaceutical industry (P),profitability of drugs operator (E),other factors affecting the proceeds of drug operators (K),additional gold cost of drugs (C1),additional cost of gold drugs sale (C2) were confirmed to be the key factors which affected the listing decision of drugs by pharmaceutical manufacturers.Governments are suggested to ensure the rational and fair use of drugs in public by policy supports,encouraging drug innovation and make-up on difference of drugs in medical institutions,optimizing benefit components of medical institutions,creating evaluation criteria for "listing value" and "necessity in clinic" of drugs.

OBJECTIVE:To introduce high-value drug insurance access mechanism in Australia,and to provide suggestion for improving orphan drug medical insurance access in China. METHODS:By literature study and policy analysis,access principle, risk-sharing mechanism and restricted use principle of high-value drug insurance access in Australia were summarized and analyzed, so as to evaluate the effects of high-value drug insurance access mechanism. RESULTS & CONCLUSIONS:The inclusion of high-value drug in Australian National Formulary considers not only the cost-effectiveness ratio,but also the drug’s clinical effica-cy,irreplaceability and the social principles;risk-sharing mechanism and restricted use principle achieve a good balance between the accessibility of patient’s medication and the sustainability of health insurance fund;remarkable results are achieved in guarantee-ing patient’s medication and strengthening basic medical insurance. It is recommended to perfect orphan drugs medical insurance ac-cess standard,introduce risk-sharing mechanism and standardize the use of orphan drugs and reimbursement in China.

Objective To investigate the correlation between plasma pentraxin 3 (PTX3)and cardiovascular disease(CVD) in maintenance hemodialysis(MHD) patients.Methods Plasma was obtained from 98 MHD patients before and after a session of HD and 50 age-matched healthy subjects.Plasma PTX3 was measured by enzyme-linked immunosorbant assay (ELISA).Spearman correlation and linear regression were used to examine the correlation between plasma PTX3 level and other laboratory parameters.Binary Logistic regression was used to assess the correlation between plasma PTX3 level and CVD.Receiver operator characteristic (ROC) curve was used to analyze the correlation among PTX3, high sensitive C-reactive protein(hsCRP) and CVD.Results Plasma PTX3 level was significantly higher in MHD patients compared to healthy controls [1.87 (1.34-2.50) μg/L vs 1.11(0.86-1.51) μg/L, P＜0.01], and increased after a single HD session[post-HD 2.18(1.80-3.14) μg/L vs pre-HD 1.87(1.34-2.50) μg/L, P＜0.01].Patients with CVD had higher concentrations of PTX3 than those without CVD[2.18 (1.48-2.74) μg/L vs 1.76 (1.25-2.26) μg/L, P＜0.05].High plasma PTX3 (＞1.87 μg/L) was positively and independently associated with CVD[OR=3.15, 95％CI(1.17-8.50), P＜0.05].ROC curve analysis showed the PTX3 was more closely correlated to CVD than hsCRP in MHD patients with hsCRP ＞3 mg/L, and the area under the curve of PTX3 and hsCRP was 0.655 ±0.083(P＜0.05) and 0.562±0.083(P＞0.05) respectively.Plasma PTX3 level was negatively correlated with body mass index (ρ=-0.248,P＜0.05), pre-albumin(ρ=-0.218, P＜0.05), total cholesterol(ρ=-0.265, P＜0.01), triglyceride (ρ=-0.246, P＜0.05), LDL-cholesterol (ρ=-0.254, P＜0.05), hemoglobin (ρ=-0.212, P＜0.05), and positively with erythropoietin dose per week(ρ=0.184, P＜0.01), cardiac troponin T (ρ=0.287,P＜0.01), carotid artery intima-media thickness (ρ=0.294, P＜0.05).Conclusions PTX3 level ismarkedly elevated in HD patients.HD procedure induces PTX3 elevation.Plasma PTX3 could be auseful marker of CVD risk factors in MHD patients.

This paper explores the relevance between data protection system and drug availability through the American lamotrigine(lamictal® )case. Results indicated that drug data protection system delays the marketing of genetics, hinders the pricing regulation of innovative drugs timely and effectively, and affects drug availability severely. With reference to America, it is urgent to design the scope of data protection system reasonably, and set the first generic drug regime and other supporting measures so as to reduce the negative effects of drug data protection system and improve the health benefits of the public.

Objective To evaluate the short-term efficacy and safety of sevelamer hydrochloride in treating maintenance hemodialysis (MHD) patients with hyperphosphemia.Methods A multicenter,open-labeled,self-control study was performed.Phosphate binders were discontinued during a two-week washout period.Patients with more than 1.78 mmol/L serum phosphorus after two-week washout period were eligible for the trial.The dose was adjusted every two weeks as necessary to achieve serum phosphorus control. Sevelamer hydrochloride was administered to 138 MHD patients for 10 weeks and a second two-week washout period followed.Results A total of 111 from 138 patients fulfilled the whole 14-week study. Mean serum phosphorus and calcium-phosphate products starte to decline after two-week sevelamer hydrochloride treatment. By the end of 10-week sevelamer hydrochloride treatment, mean serum level of phosphorus [(1.85±0.50) vs (2.57±0.54) mmol/L,P＜0.01],calcium-phosphate product [(4.16± 1.72) vs (5.79 ± 1.50) mmol2/L2,P＜0.01 ] and low density lipoprotein [(1.64±0.76) vs (2.31 ±0.87) mmol/L,P＜0.01] were significantly decreased,while the adjusted serum level of calcium and serum intact parathyroid hormone kept steady.Both serum phosphorus and calcium-phosphrus product increased after the second washout period, but the levels were still lower as compared to pre-treatment [(2.26±0.71) vs (2.57±0.54) mmol/L; (5.12±1.63) vs (5.79±1.50) mmol2/L2,P＜0.01].Of the 138 patients involved,214 episodes in 106 patients and 121 episodes in 89 patients were reported as adverse events and adverse drug reaction respectively. Gastrointestinal symptoms,of which most were mild or moderate,happened to 68.1％ (94/138) patients. Conclusions Sevelamer hydrochloride can control serum phosphorus and reduce the levels of calcium-phosphorus product and cholesterol.Slight gastrointestinal symptoms like constipation are common during the treatment.

Abstract: In order to ensure the safety and efficacy of generic drugs for the substitution of narrow therapeutic index (NTI) drugs, and to improve and optimize China's generic drug substitution policy, we searched foreign literature databases and government websites to collect and sort out the typical measures taken by some foreign countries to ensure the safety and efficacy of generic drugs for the substitution of NTI drugs, including R&D registration, generic drug substitution and post-market surveillance. On the basis of comparative analysis, this paper summarizes the practices China can learn from. It can be seen that there are problems and challenges in China's generic drug substitution for NTI drugs, such as unclear targets for bioequivalence studies of NTI drugs, insufficient rational decision-making basis for generic substitution of NTI drugs, and imperfect post-market surveillance system, etc. It is recommended that we should formulate a list of NTI drugs, play the roles of physicians and pharmacists in generic drug substitution, adjust the generic drug substitution for NTI drugs according to the level of risk of drug use, and improve the reporting system for adverse reactions due to generic drug substitution.

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.

OBJECTIVE：To provide reference for further standardizing and improving the selection of essential medicine in China. METHODS ：The selection mode of essential medicine in South Africa was introduced ，involving organizational structure and responsibilities ，selection criteria ，selection procedure ，dynamic adjustment mechanism and implementation effect. The suggestions were put forward for improving selection mode of essential medicine in China. RESULTS & CONCLUSIONS ： Pharmaceutical and Therapeutics Committees at all levels in South Africa were responsible for collecting applications for essential medicine and submitting them to the Rational Selection Group for preliminary screening ，which was finally decided by the National Essential Drugs List Committee ；the selection criteria was mainly based on WHO essential medicine selection criteria ；the selection basis of essential medicine in South Africa was based on standard treatment guidelines ；a bottom-up normalized user feedback mechanism was established to dynamically adjust the list ，and more attention was paid to drug evidence and evidence level in the review process ；the review points tended to focus on evidence and the level of evidence. In general ，the selection of essential medicines in South Africa had high recognition and good application. It is recommended that China appropriately refer to the practice of South Africa ，take clinical guideline as one of the selection criteria ，establish daily gradual feedback channels ， strengthen the review of evidence ，unify Chinese evidence grading system ，and combine Chinese national conditions to finally explore a selection model for essential medicine with Chinese characteristics.

OBJECTIVE：To analyze the application of health technology as sessment（HTA）for the selection of essential medicine in Thailand ，and to provide reference for optimizing the selection system of essential medicine in China. METHODS ：By retrieving related literatures and official websites ，the situation （selection mode ，institution and HTA institution ），process（main selection process of selection for essential medcine ，HTA process ） and supporting measures （HTA guideline ，HTA research database，standard cost list ）in the selection of essential medicine in Thailand were analyzed comprehensively. Suggestions to essential medicine selection in China were put forward. RESULTS & CONCLUSIONS ：The current selection model of essential medicines in Thailand is based on the application of stakeholders （pharmaceutical manufacturers ，healthcare providers ，patients or patient organizations ，etc.）through expert selection combined with HTA ，which is charged by essential medicine list subcommittee. The Health Intervention and Technology Assessment Program Center of its health economics working group is responsible for the specific work of essential medicine HTA. Its main process include the submission of applications by pharmaceutical manufacturers ， screening by essential medicine list committee ，expert selection ，and the coordination working group of essential medicine list to form the proposed list ，which is then examined and approved by the subcommittee ，minister of Health and National Drug System Development Committee ；finally the list was released. The high-price but necessary drugs are selected by the subcommittee and then the priority is assessed by the health economics working group. Non-profit organization or other interested organizations conduct HTA ；health economics working group and external audit experts evaluate the research quality ，and the health economics working group forms policy recommendations ； NLEMcommittee will carry out list access or price negotiation which then were considered by the subcommittee. In HTA supporting measures of Thailand ， HTA guidelines include HTA methodology guidelines （ensuring high quality economic evaluation and prom oting standardization of research fr amework）and HTA process guidelines （HTA is strictly regulated from transparency，accountability，inclusiveness，timeliness，quality，consistency，competitiveness）. HTA database include 4 kinds of economic evaluation researches （cost minimization analysis ，cost-benefit analysis ，cost-effectiveness analysis and cost-utility analysis），result evaluation ，quantitative research of life quality ，which supplied reference for research staff. The standard cost list makes the economical evaluation process more accurate and convenient. The selection of essential medicine in China can refer to the relevant experience of Thailand ，gradually establish health technology assessment system ，strengthen international cooperation and personnel training ；introduce the concept of priority ，and reasonably allocate evaluation resources ；formulate HTA guidelines ， improve supporting measures ；emphasize the participation of stakeholders to ensure the standard and transparent selection process ， so as to continuously improve corresponding selection system in China from aspects of the system construction ，resource allocation，supporting measures ，program optimization ，etc.

OBJECTIVE： To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS： The design and relevant laws of drug reevaluation system in America， European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS： America， European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs， as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system， post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs， drugs licensed under exceptional circumstances or conditions， and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system， reevaluation system and other systems. However， there are still some shortcomings in the drug reevaluation in our country， such as weak system， weak legislation， inadequate operability and deterrence， ineffective links between the implementation and application of drug evaluation results， and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China，starting from the systematic construction of the legal system of drug reevaluation， the construction and standardization of the legislative level， the connection of the legal system of drug reevaluation and the allocation of resources.