OBJECTIVE:To improve response capacity of China to deal with intellectual property rights protection standard terms (Trips-plus terms) beyond the regulations of Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and to provide reference for improving national intellectual property rights protection policy. METHODS:Trips-plus terms and their common types were introduced to analyze their characteristics and consider about their adverse effects. RESULTS & CONCLU-SIONS:Common TRIPS-plus terms involve data protection,patent interlinkage,patent period extension,limitation of compulsory licensing and parallel importation,etc. These terms pose a significant challenge to developing countries,resulting in delaying entry of generics,increasing drug price,influencing drug accessibility and posing a great threat to public health. China,as the largest de-veloping country mostly relying on generic drugs,should scientifically assess the effects of TRIPS-plus on public health,drug ac-cessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement,and make effec-tive use of the TRIPS flexibility to protect the public health.

OBJECTIVE:To discuss how to solve patents problems in the registration and approval of drugs.METHODS:Regulations and problems in the registration and approval of drugs in China were analyzed and which were compared with that of the American and Europe.RESULTS&CONCLUSIONS:The registration and approval of drugs and their patents right protection were legally independent of each other,to which the drug administration law and patent law respectively are appli-cable.There is no necessary association between the registration and approval of drugs and the infringement of patents right.Patent dispute should be solved in accordance with the patent related regulations,the registration and approval of drugs should not involve the solving of patent disputes of drugs.

OBJECTIVE: To design an attitude scale for the investigation of the factors that influence prescribing and to promote clinical pharmacists' effective intervention on physician's prescribing behavior. METHODS: The factors influencing physicians' prescribing behaviors were investigated; using psychometric psychological measurement standards to determine the objective and contents of the attitude scale. Question types were appropriately chosen, questions were designed skillfully, and the attitude scale was pre-tested and revised. RESULT & CONCLUSION: A comprehensive, reliable and standard attitude scale is conducive to the rational use of drugs in the clinic.

OBJECTIVE:To provide reference for perfecting the "Regulation of Drug Price Difference" issued by National Development and Reform Commission.METHODS:To review the drug price management course in China,analyze the effects and limitations since the initiation of "Regulation of Drug Price Difference" in 12 hospitals in Beijing and put forward suggestions for its improvement.RESULTS & CONCLUSIONS:"Regulation of Drug Price Difference" has contributed to the formation of unified and standard evaluation criterion and computation method or even the holistic evaluation system in drug pricing management,the lowering of the costs of human factors and administrative management in drug price management and the improvement of the governmental pricing efficiency.However,efforts should be taken to improve the unreasonable drug price difference coefficient and computation method and so on.

By analyzing relevant documents of procurement of drugs with target quantity in Shanghai, com-bined with onsite investigations and interviews, this paper summarizes the practice of procurement of drugs with target quantity in Shanghai from six aspects, namely the basic situation of centralized procurement, pilot scope and variety of procurement of drugs with target quantity, business qualification and certification, determination of successful bid-der, drug distribution, and drug payment settlement. This paper argues that Shanghai has successfully implemented the policy of procurement of drugs with target quantity, by scientifically establishing a comprehensive evaluation index of quality, setting up private drug procurement accounts, prepaying drug procurement loans and strengthening plat-form services and regulatory capabilities, in order to effectively guarantee the operation of procurement of drugs with target quantity. From this case study of Shanghai, it can draw the following implications that in order to successfully achieve procurement of drugs with target quantity mechanism, setting up functional departments of unified authority is the most important guarantee, and using technical means and platform building is the basic conditions. Therefore, the setting up of economic and technical bidding should focus on the individual properties of generic drugs, and the pro-moting of tripartite system reform will help to further expand the scope of procurement of drugs with target quantity.

OBJECTIVE:To provide reference for improving the drug price regulation policy in China. METHODS:Literature research,system comparison and other methods were used to summarize the commonalities and characteristics of drug price regula-tion policy in Germany,Japan and Taiwan area of China,and the successful experience was learned. RESULTS & CONCLU-SIONS:Drug price management in Germany,Japan and Taiwan area of China has their own characteristics. Germany conducted reference price system and new drug pricing mechanism,which was the first country to introduce the reference price system. Japan granted price premiums to innovative drugs,decreased pricing for generic drugs and adjusted drug price again. And Taiwan area of China classified and grouped differential pricing to encourage competition negotiation and regularly investigated drug prices and pric-ing. Germany,Japan and Taiwan area regard medicare pay price as core of drug price management,adopt comprehensive means to regulate the drug price,and pay attention to the monitoring and regular adjustment of market price as well. Price negotiation,phar-macoeconomics and multiple pricing methods are broadly used. Value-based drug pricing system is new trend of price policy re-form. It can be used for reference to improve the drug price regulation system in China.

OBJECTIVE:To study the development and status quo of narcotics and psychotropic substances (NPS) in China since 1949,and to provide evidence for perfection of NPS control work in China. METHODS:The development and status quo of controlled substances control by China since 1949 were summarized and analyzed through retrieving and collecting literatures,re-ports and policies about NPS from domestic and foreign databases,news reports and related website. RESULTS & CONCLU-SIONS:Chinese narcotics and psychotropic substances control dated back to the release of Interim Regulations on Narcotics Con-trol in 1950 and Regulations on Narcotics Control,Drug Administration Law and other regulations have been issued. It had experi-enced the progress from no legal basis to having laws to follow and from executive-leading to legalization. Narcotics and psychotro-pic substances were gradually unified in systematic control,and the level of regulations rised from department rules to administra-tion regulation. At present,with Regulations on Narcotics and Psychotropic Drugs Control (2005) as regulatory basis and cata-logue of narcotics and psychotropic substances(2013)as object,China Food and Drug Administration are in charge of the national regulation,cooperating with health department,agricultural department,traffic department and other departments.

OBJECTIVE:To study the development and status quo of controlled drugs control in Britain,and to provide evi-dence for narcotics and psychotropic substances(NPS)control in China. METHODS:The development and status quo of NPS con-trol by Britain were summarized and studied through retrieving and collecting literatures,reports and policies about NPS from do-mestic and foreign databases,news reports and international website. RESULTS & CONCLUSIONS:British control for controlled drugs dated back to Pharmacy Act in 1868,and Britain was the first country to control drugs by legislations. A unique British sys-tem of narcotics control was established and improved after issued Rolleston Report and two pieces of Brain Report in Britain. Final-ly,the British system of narcotics control was established,which combined public health prevention with judicial redress. At pres-ent,controlled drugs are classified and controlled by Advisory Committee on Drug Abuse,Serious Organised Crime Agency and National Drug Abuse Treatment Agency subordinated to Ministry of Interior,based on Misuse of Drugs Act.

OBJECTIVE:To study the development and status quo of controlled substances control in the United States,and to provide evidence for narcotics and psychotropic substances (NPS) control in China. METHODS:The development and status quo of controlled substances control by the United States were summarized and studies through retrieving and collecting literatures,re-ports and policies about NPS from domestic and foreign databases,news reports and international website. RESULTS & CONCLU-SIONS:The United States'control for controlled substances dated back to Harrison Narcotics Tax Act in 1914,and the United States is the first nation to control narcotics addiction through the form of tax law after International Opium Convention is executed. Thereafter,the United States gradually extend the range by including cannabis,heroin and psychotropic substances into control range of Narcotics Drugs Import and Export Act,Heroin Act,Marijuana Tax Act,revising and developing comprehensive act Con-trolled Substances Act,and establishing comprehensive law enforcement agency Controlled Substances Enforcement Administration affiliated to Ministry of Justice by Nixon'sWar on Drugsplan.

OBJECTIVE:To study the development and status quo of international narcotics and psychotropic substances (NPS)control,and to provide evidence for NPS control in China. METHODS:The development and status quo of NPS control by international organization were summarized and studied through retrieving and collecting literatures,reports and policies about NPS from domestic and foreign databases,news reports and international website. RESULTS & CONCLUSIONS:International narcot-ics control dated back to opium trade with China in 19th century. International narcotics control system was established preliminarily by Shanghai conference and Haiya conference. The end of World War Ⅰ,the establishment of the League of Nations and the sign-ing of a number of international treaties promoted the development of internal control system. Through World War Ⅱ,the establish-ment of the United Nations and the change of international control organization,a number of international treaties were integrated into Single Convention on Narcotic Drugs in the early 1960s,which was used as the foundation of narcotics control system all round the world. In 1970s,the adoption of Convention on Psychotropic Substances meant psychotropic substances were included in the scope of internal control. In 1980s,the signing of United Nations Convention against Illicit Traffic in Narcotic Drugs and Psy-chotropic Substances marked the establishment of three conventions system of international NPS control. At present,internal NPS control is based on three conventions system and NPS list by Commission on Narcotic Drugs,International Narcotics Control Board and United Nations International Drug Control Program. The vast majority of countries are parties to that. International control orga-nizations and listed control have a great influence on NPS control all round the world.