Bolar exception is a patent infringement exemption principle .The article explored the origin ( market failure ) of Bolar ex-ception from the view of government regulation theory , and introduced the production , development and application status of Bolar excep-tion in the world.At the same time, the Bolar exception clauses in our country were also introduced , and the relative regulations in time, place and application scope were discussed in order to provide reference for the perfection of Bolar exception in China .

Objective:To establish the competency model for medical representatives in China. Methods:Firstly, the competen-cy elements for medical representatives were defined through the literature research and logic analysis, the importance of each element was then evaluated by a questionnaire, and the survey results were analyzed by a factor analysis approach. Lastly, the weight of each factor was confirmed by analytic hierarchy process. Results & Conclusion: The competency model, which consists of 5 dimensions ( professional quality, professional ethics, knowledge, personal characteristics and relationship management) , 26 competency elements and the weight of each factor, is established successfully.

Objective:To explore the diagnostic value and correlation of serum tumor markers combined detection of pancreatic cancer. Methods:Selected January 2013 to may 2016 in our hospital in patients with pancreatic cancer in 146 cases,128 cases of non pancreatic cancer with patients and 124 cases of healthy physical examination. Radiation immunity analyzer test groups of serum CA19-9,CA242,CA50,CA125,CEA and TSGF levels and compared between groups. To draw the working characteristic curve(ROC) to analyze the diagnostic value of tumor markers in patients with pancreatic cancer and the correlation of linear correlation analysis of tumor markers. Analysis of independent risk factors for pancreatic cancer using multiple logistic regression models. Results: The pancreatic cancer group of serum CA19-9,CA242,CA50,CA125,CEA and TSGF levels were significantly higher than the control group and non pancreatic cancer group,the differences were statistically significant(P<0. 05 or P<0. 01).Ⅳstage andⅢstage with patients of serum CA19-9,CA242,CA50,CA125 and TSGF levels were significantly higher than Ⅰstage and Ⅱstage with patients(P<0. 01).Ⅳ stage with patients of serum CA19-9, CA242, CA125 and CEA levels were significantly higher than Ⅲ stage with patients ( P<0. 01). The pancreatic cancer group of serum CA19-9,CA242,CA50,CA125,CEA and TSGF of positive rate were significantly higher than that of control group and non pancreatic cancer group(P<0. 01). ROC curves showed that the AUC of serum CA19-9 were higher than other single indexes,the best critical value,sensitivity and specificity were 114. 5 U/ml,81. 2% and 79. 3% respectively. The diagnostic efficacy of the six joint detection were better than the single detection,the sensitivity and specificity were 92. 4% and 76. 5%respectively. Correlation analysis showed that serum CA19-9 were positively correlated with CA242,CA50 and CA125(r=0. 703,P=0. 005;r=0. 572,P=0. 024;r=0. 439,P=0. 036). Multiple logistic regression analysis showed that smoking,incorrect diet,history of diabetes,gallbladder disease history and high levels of CA19-9,CA242,CEA into the regression model,the OR value and 95%CI were 1. 717(0. 736 to 2. 359),2. 865(2. 217 to 3. 685),2. 614(2. 186 to 3. 127),3. 527(2. 842 to 4. 377),4. 214(3. 570 to 4. 962), 2. 315(2. 114 to 2. 539),1. 876(1. 175 to 2. 852). Conclusion: Serum tumor markers combined detection can help to improve the accuracy of early diagnosis of pancreatic cancer and smoking,incorrect diet habits,history of diabetes,biliary disease history and high levels of CA19-9,CA242 and CEA are independent risk factors for pancreatic cancer.

OBJECTIVE:Analyze drug use of pediatrics in China,and to provide reference for promoting research,develop-ment and supply of pediatric drugs. METHODS:Analyze the data of drug use in 2 632 514 pediatric patients aged from 0 to 14 of 78 sample hospitals from Beijing,Shanghai,Tianjin,Hangzhou,Zhengzhou,Guangzhou and Chengdu in“The Hospital Prescriptions Cooperation Project”of Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association,statistical analysis was performed by using Excel and Access software. RESULTS:Pediatric patients in 78 sample hospitals of 7 regions had used 1 572 kinds of drugs from 2013 to 2014,but only 31.04%of drugs were pediatric drugs;both the ratio of pediatric drug types and the ra-tio of pediatric drugs use frequency had a great gap in different drug classifications. The ratio of drug use frequency in injection ad-ministration was 57.97%,and it was greatly higher than that of oral administration(31.04%). Among oral solid preparations,the ratio of drug use frequency for drugs with unreasonable specification was 29.57%,and ratio of drug types was 40.99%. CONCLU-SIONS:The pediatric patients had a great drug shortage in kinds,dosage forms and specifications in 78 sample hospitals of 7 re-gions during 2013-2014. Off-label drug use,high frequence of injection use,tablets used after breaking and other irrational phenom-ena were found in pediatric patients during clinical drug therapy,which reduced high risk of drug use. It is recommended that gov-ernment should strengthen and improve incentives mechanism of research,development and supply of pediatric drugs,so as to solve pediatric drug shortage in China,promote rational clinical drug therapy for children and guarantee the safety of drug use in pe-diatrics.

OBJECTIVE:To provide reference for the promotion of rational use of essential medicines and further implementa-tion of essential medicines system. METHODS:Depended on the data (including the number of species,the amount of prescrip-tion and prescription departments,etc)of essential medicines(chemical drugs and biological drugs)use in outpatient and emergen-cy departments and wards of 20 sample medical and health institutions fromThe Hospital Prescriptions Cooperation Project,statis-tical analysis was performed by using Excel and Access software. RESULTS:The proportion of the amount of essential medicines included in National Essential Medicines List(2012 edition)or Beijing Essential Medicines(Supplementary list)(2012 edition)to the amount of total medicines(hereinafter referred to as the essential medicines use ratio)in medical and health institutions of Bei-jing from 2013 to the first half year of 2014 was small and showed a slight downward trend. The essential medicines use ratio of grade 2 and grade 3 general hospitals did not reached the required ratio by former Health Department. The essential medicines use ratio in different departments showed great differences,the essential medicines use ratio in imaging department was 100%,while chemotherapy departnent was 4.04%. The essential medicines use ratio in different medicines also showed great differences,5 kinds of drugs(including sulfani lamides)was 100%,while there were 16 kinds of drugs that was less than 0.1%. CONCLUSIONS:The essential medicines use ratio is relatively low in medical and health institutions of Beijing from 2013 to the first half year of 2014 and shows great differences in different departments and different medicines. It is suggested to further improve the essential medi-cines use ratio to better benefit the majority of patients by changing the prescribing habits of physicians,strengthening the advocacy of essential medicines policy and optimizing the use of essential medicines in different departments.

This article is to analyse the development of therapeu-tic biologics from 1984 to 2014. Data were obtained from the Drugs @ FDA, PubMed, Embase. com and ClinicalTrail. Gov. Descriptive analyses were used to classify therapeutic biologics by level of innovation,therapeutic category and the chemical na-ture of the drugs. The results showed that from 1996 the thera-peutic biologics entered the fast development period, especially from 2001 to 2005. The 125 therapeutic biologics focus on the treatment of tumor, immune system disease, endocrine and met-abolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic bio-logics. Antibody is widely used in the treatment of cancer, di-gestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.

The paper studied the development opportunities and challenges faced by private hospitals during the ongoing health reform and reviewed the milestones of such hospitals in China.In addition,it compared the developments of both private hospitals and public hospitals since the reform,analyzed the advantages and disadvantages.Based on such analysis,the paper proposed such business strategies as group strategy and differentiation strategy,pointing the way for further development of private hospitals.

Objective To investigate the incidence of live births with Down syndrome(DS) in Sanya city as well as to discuss the related risk factors .Methods The object of investigation was the 25 032 infants who were born in Sanya city ,then the children with clinical suspected of DS were confirmed by peripheral blood chromosome analysis .Meanwhile ,the clinical data of children and their parents were collected ,calculating the incidence of DS in this region and analyzing the related risk factors .Results In this region , the total incidence of DS was 0 .959‰ ,the incidences in the Han nationality and Li nationality were 0 .834‰ ,1 .442‰ respectively . The mean age of DS children′s mother was 29 .8 years old ,and the incidence of DS increased as their mother grew older .Before pregnancy ,DS children′s mother who had an exposure history of toxicant and drugs accounted for 45 .8% .Conclusion The inci‐dence of DS in Sanya is quite high ,so it is extremely essential to strengthen the women′s pregnancy Down syndrome screening and improve the prenatal diagnosis in this region .

OBJECTIVE： To analyze the effect of the national designated production pilot policy for drug in shortage in China. METHODS： Taking 2 batches of drugs from 7 designated production manufacturers in Chongqing from Sept. 2012 to Sept. 2018 as an example， the overall supply situation of designated production （using the average satisfaction rate of medical institution’s order as index）， the changes of drug supply （average satisfaction rate of order） before and after the implementation of national designated production policy （during designated production period and non-designated production period） were all analyzed. According to the level of medical institutions and the order quantity of medical institutions （three sections： small amount， suitable， big amount）， the classification analysis was carried out. At the same time， telephone interview was conducted among the business personnel of related pharmaceutical production enterprises to understand and summarize the reasons for the supply problems of these drugs. RESULTS： Except for the average satisfaction rate of drug order was 0 in one designated production manufacturers， the satisfaction rate of drug order in the other 6 designated production manufacturers ranged from 58.05％ to 92.31％. During the designated production period， the satisfaction rate of drug order was increased significantly， compared with non-designated production period. However， after the expiration of the designated production of drugs， the order satisfaction rate mostly declined， and satisfaction rate of some drug orders were even lower than that before designated production. Average satisfaction rate of drug order in third level medical institution was higher than those of second level， first level or primary medical institutions. During designated production period， the average satisfaction rate of drug order in designated production manufacturers to medical institutions at all levels was higher than during non-designated production period or in non-designated production enterprises. There are 5 kinds of reasons for supply problem of designated production and drug with same specification： the limited price is lower than the cost； the production is stopped due to raw material； the production is stopped because of enterprise； the medical insurance payment price is far lower than the supply price； the hospital demand is small. CONCLUSIONS： The designated production pilot policy has played a significant role in improving the shortage of drug supply， but it still needs to be improved by establishing a dynamic adjustment mechanism for the scope， price and duration of designated drug production.

OBJECTIVE： To provide reference for further evaluating， improving and ensuring the smooth implementation of centralized drug purchase and use pilot organized by the state. METHODS： By using the methods of literature research and investigation， monitoring purpose， monitoring contents （including supply guarantee， use guarantee， quality guarantee and cost control） and monitoring methods of Monitoring Programme for Centralized Drug Purchase and Use Pilot Projects Organized by the State were sorted， summarized and analyzed so as to put forward the suggestions.  RESULTS & CONCLUSIONS： The monitoring purpose was to control the procurement phase from two aspects： policy guidance and information monitoring. In the contents of monitoring， monitoring indicators were set up for supply gurantee from two aspects of production and circulation. The former included seven indicators of production inventory， stop and resume production， source and supply and price of core raw materials and accessories， and the latter included two indicators of channel inventory and days of repayment. For use gurantee， selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored in respects of monthly purchase price， purchase quantity， purchase amount， accumulative purchase quantity， accumulative purchase amount， prescription quantity. Quality gurantee indexes included drug stability （batches and projects of unqualified drugs）， safety （ADR， severe ADR， public complaints and reporting incidents） and effectiveness （number of drug-change patients and number of secondary drug-change patients）. For cost control， the monthly drug quantity and cost of selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored； original drug cost （for original drugs in the term of same generic name）， the cost of other drugs and the reimbursement ratio of last year’s medical insurance （for other drugs in the term of generic name） were compared with the same period of the previous year， in which the drug quantity was calculated by DDDs. The monitoring methods included three-level monitoring by the national organization office for the contralized procurement and useage of pharmaceuticals， “4+7” city joint procurement office and pilot area， and regular monthly reporting and timely feedback of monitoring information. Monitoring information submission was mainly in the form of standardized report format （filling by manual in monthly， e-mail submission） and automatic system submission （every day， other pilot cities and Shanghai Joint Purchasing Data Exchange Platform established data interface for automatic submission）. According to the fact， author put forward the suggestions to improve the monitoring contents， such as adjusting the measurement standard of inventory turnover days， defining the statistical caliber of purchasing quantity and price monitoring， distinguishing the specifications of pharmaceutical preparations and packaging， defining the every drug DDD value in monitoring range， and so on. At the same time， the author suggests optimizing the reporting mode of monitoring information， interworking the purchasing platform with medical insurance information， and integrating drug supply chain information from manufacturing enterprises， distribution enterprises， medical institutions to patients， providing cross-provincial trading services， etc.， make them play a greater role in drug procurement management of the National Healthcare Security Administration， rational use management of drug by the Nation Health Commission of the People’s Republic of China， and drug traceability management of the National Medical Products Administration.