Research On The Prevention And Relief System Of Drug Accident

Drugs could cure or cause an illness, could strengthen or hurt a body, and could also rescue or harm a life. The coexistences of their active and adverse reactions, and effectiveness and danger make it necessary to establish and improve prevention and relief systems related. It is only in recent years that China has attached importance to the problem because of the frequently happened drug-induced injury accident. However, legislations are only aimed at solving concrete problems and lack systematic and proactive thought. Therefore, I would try to make a systematic study on prevention and relief systems of drug-induced injury accident in the dissertation. Based on analysis of legislation, cases and theory of U.S.A., German, Japan and other developed countries, Chinese legal systems, and development status of our pharmaceutical industry, I study systematically on administrative regulation of drugs, determination of defective drugs, relief of defective drugs and special relief of adverse drug reaction, and provide integral suggestions for constructing Chinese prevention and relief systems of drug-induced injury in aspects of protecting the injured and promoting the even development of pharmaceutical industry. Besides of the part of introduction, there are five chapters and a conclusion, the main contents of which are:Chapter?Basic Concepts and Introduction of Problems. I firstly limit the concepts of "drugs" and "drug-induced accident". According to a study on related concepts and a historic analysis of several serious drug-induced accidents, I specify the importance and necessity of establishing and improving prevention and relief systems of accidents. On basis of analyzing characters of drugs and drug-induced accidents, I promote my suggestions of establishing prevention and relief systems of the accidents, which are to let government play a main role to emphasize prevention, to determine strictly the standards of drug quality and defects, to improve the tort relief system of drug damages, to strengthen ex post punishment and to establish the relief systems of adverse drug reactions.Chapter?Role of Government:To Strengthen Administrative Regulation. Because of the complication of pharmaceutical technology and its high extent of specialization, it is necessary to make government to play a main role and regulate the whole process of research, development, sale, consumpation and adverse reaction supervision. In view of the achievement of FDA in field of drug supervision and regulation, we could learn from their successes. Therefore, I introduce the supervision and regulation systems and practices of U.S.A. and conclude their experiences firstly. Then I describe the status quo of Chinese drug regulation, and conclude that China should improve drug standards and strengthen supervision of information disclosure of pharmaceutical industries, permission before entering into market and regulation afterwards to prevent drug-induced accident as possible as we can.Chapter?Determination of Defective Drugs:To Improve Standards. Determination of Defective Drugs, which is critical and basic to prevent and solve drug-induced accident, has always been a focus of discusses since it is not only a technological problem, but related to value tendency and interest orientation. In this chapter, I make a study on several controversies, i.e. whether drugs matching country's standards could be defective, whether drugs could be regarded as defect because of causing adverse reaction, and the time bases of determining defective drugs. Then I analyze several standards of determining defective drugs, different requirements of the main defects and relation between administrative regulations and relief according to tort law. We should not regard the standards stipulated in law as unique, but "basic", should take the time drugs enter into market as one to judge whether they are defective, clarify standards of different defects and distinguish drug defect and its adverse reaction.Chapter?Application of Tort Liability:To Improve Rules. I firstly probe into the rational liability rules in aspect of comparative laws and conclude that the rules of drug-induced accidents have all experienced a development from negligent liability to no-negligent liability to protect interests of the injured. However, a new tendency has come into being according to some cases of U.S.A. and rules of the Restatement of Tort Law, that is, to restrict the application of no-negligent liability and to apply different standards on different defects. Then I study the components of tort relief in drug-induced accidents, which are emphasized on limits of damages, including whether moral damages should be compensated and how to apply punitive compensation, and the determination of causation between drug defects and damages. I analyze probability theory of causation, theory of epidemic causality, theory of market share, and other special causality, rules of statutory presumption of causation in German Drug Law, rules of the victims claim knowledge and expert testimony rules in American law. Lastly, I study the accountability and exclusion of tort liability of drug-induced accidents, including bodies of responsibility, the emphasis of which is whether medical institutions should bear no-negligent liability for damages because of defective drugs; exclusion clauses, emphasizing on whether exclusion claims of technology status should be applied to damages of defective drugs, and ways to protect the injured if applied; problems of litigation limitation and scheduled period, which are based on different stipulations in German and Japan to improve Chinese rules.Chapter?Relief for Damages of Adverse Drug Reactions:To Establish Applicable Institution. There are many differences of legislative attitudes and institutions design among countries:some stipulate that pharmaceutical industry should bear tort liability; some enact Drug Relief Act and set up special relief fund; some force pharmaceutical manufacturer to insure or establish drug insurance system. However, there only exist special stipulations on adverse vaccine reaction, but no relief systems of adverse drug reaction. In the chapter, I firstly probe into the tort relief model of drug adverse reaction and Vaccine Injury Compensation Program used to make up its defects in several states of U.S.A., and conclude the experiences we could learn from. Secondly, I find reasons of its success by studying the model of insurance relief in Sweden and German, that is, there are advanced social relief systems, wholesome insurance system and other ways. Thirdly, I study the model of relief fund in Japan and Taiwan. There is notable superiority in spite of some problems. Therefore, we should absorb the above two models and establish a system mainly based on fund relief and supplemented by insurance relief.