A Study On China's Drug Safety Regulation

With the social development and strengthening of people's health consciousness, drug safety has been widely taken seriously and become common concerned subject in fields as economics and laws. Regulation of drug safety is the administrative and technical supervision, originated from public benefits and legally entitled, of the whole process of drug research and development, produce, sale and appliance. It becomes a hard problem for the reform to confirm each reasonable benefit threshold in adjusting the relationship among government, enterprises and consumers during this course.Since 1998, China has experienced two big system reforms of drug safety regulation. The 2008 reform of governmental organizations turned the former drug supervision structure from line management below province to management at different local levels. Aiming at strengthening the government responsibilities and ensuring the relative independent law enforcement of drug supervision department, this reform has gained outstanding achievement in practice. However, there are still drug safety problems unsolved, such as counterfeiter and low quality drugs, ADR and unreasonable use of drugs. In recent years, harmful events like counterfeiter medicine of Qiqihar NO.2 pharmaceutical company and Shanxi vaccine made great injuries and negative impact to public health, life safety and social stability. For all these reasons, it is urgent for China to enhance drug safety supervision and improve regulation ability to make a better drug safety, safeguard consumers'health from injuries and ensure public drug use safety.From the view of regulation economics, the dissertation collects and evaluates the international and national literatures on drug safety regulation, makes economic analysis of drug safety regulation, constructs a game theory model of it, deeply discusses the relationship between government and enterprises, enterprises and drug consumers, discloses the conditional factors of drug safety regulation reform, and further makes conclusions that:(1) the result of pure strategy Nash equilibrium between government and enterprises is an ideal state. Although under the legal frame and supervision of social intermediary organizations as public opinion and pharmaceutical industrial associations, each side will take the optimal strategy based on the other side's strategy, thus only mixed strategy Nash equilibrium could exist. (2) The optimal supervision probability is greater under the collusion of regulatory organizations and enterprises than the noncollusion situation; the violation probability increases too. The fatal penalty of regulation organizations can effectively frighten enterprises, and meanwhile enterprises, thinking of long run development necessity, could positively cooperate the supervision under the pressure of public opinion. (3) During the course of game between enterprises and drug consumers, the inferior position of consumers decides that the ideal state which maximizes n* (consumer purchase ability) and minimizes a* (shoddy probability of enterprise) can't be realized. In the long run, the reverse choice of "counterfeiter drives out effective medicine" in whole market decreases the total social benefit. Theoretical analysis explains the historical trace and effectiveness of Chinese drug safety regulation, and reflects main problems in this field:unsound system of drug safety regulation laws, omission of governmental administrative enforcement, lax implementation of market entrance system for drugs, imperfect reform of medical care system, and undutiful industry associations, etc. The game theory analysis of drug safety regulation also reveals the deep-rooted reasons - the responsibility of mainstay of regulation is uncertain, the enforcement resource allocation of regulation institutions is unreasonable, the regulated has weak self-discipline, the multi-linked supply chain results in decrease in drug supply efficiency, regulation departments is captured by enterprises, the self-supervision system is weak, and technologies of ADR monitoring is inefficient, etc.Using comparative study method, the dissertation analyzes typical drug safety regulation system and regulation practice of developed countries. The rather complete drug safety regulation system, law system and sound drug recall system of developing countries offer experiences for Chinese regulation reform. Perfect law system is the basis, building independent and highly effective drug safety regulation institutions, strict enforcement and highlighted regulating emphasis is the key. The role of expert consultation committee should be emphasized, recall system should be improved, and the supporting role of technologies should be stressed. At the same time, it should be seen that this regulation in developing countries is not perfect either; sometimes they may not suit Chinese nation conditions.Besides the above, the dissertation also advances some countermeasures for improving drug safety regulation, based on the developing reality of China and the analysis result of the game. Countermeasures include:(1) improving the structure of drug safety regulation. Such as choosing the appropriate regulatory agency reform program to improve the effect of the regulation; accelerating the development of civil society and fully playing the role of industry association. (2) improving the system of drug safety regulation. Such as improving statutes construction and regulation efficiency to improve regulatory efficiency; laying stress on drug quality safety regulation and heightening regulation level; enhancing this regulation in countryside and improving its drug market environment; deepening medical care system reform and upgrading the effectiveness of drug safety regulation; encouraging general public to join in and enhancing social supervision; improving drug safety responsibility system to improve the credibility of the government.