Research On Drug Product Liability

AbstractDrug is used for the prevention, treatment and diagnosis of disease. It can also adjust people's physiological function purposefully and prescribe for certain indications with appropriate methods and quantity. There are many kinds of drug, including Chinese herbal medicine, herbal slice, Chinese patent medicine, chemical pharmaceuticals and their galenical preparations, antibiotic, biochemical drug, radioactive drug, blood serum, vaccine, blood coagulation, diagnostic drug and etc. Drug plays an important role in removing disease and pain from mankind. However, drug is special merchandise which involves characteristics ordinary merchandises do not have. For example, drug is a two-edged sword, which means it not only has the effect for curing and preventing disease, but also has side effects. If drug is used appropriately, it can cure people. But if it is used inappropriately, it may damage the health of people or even endanger their lives. Whether drugs can play the role for curing and preventing disease depends on its quality.The author combines the product liability system, and mainly applies product quality law and infringement responsibility law to demonstrate the composition of the drug infringement responsibility. The thesis contains five chapters.The first chapter Introduction summarizes the background, current situation of domestic and foreign, research idea of this essay, key issues to be solved, the significance of choosing this subject and the innovation of this essay. Setting out from the definition of drug, the second chapter"summary of drug and infringement responsibility"recounts the quality and peculiarity of drug and mainly demonstrates infringement responsibility and the four kinds of imputation principle and composition; The definition, current situation, type and composition of adverse drug reactions; The chapter mainly demonstrates infringement responsibility, the four kinds of imputation priciple and constitutive requirements; Production responsibility and product defect theory is the entering point of this essay. Product responsibility is a common form of infringement responsibility. Unressonable danger is the essence of product defect, which is the theory basis for research on drug infringement responsibility in the following text.According to the component of infringement responsibility, the third chapter"Research on drug product liability"which is also the focal point of this essay, it puts forward the concept of drug infringement which as a whole refers to the civil responsibility that should be burdened due to drug infringement according to law. The author defines the research range to the infringement responsibility when personal right and property right are damaged owing to the flaw of drug. And the responsibility refers to the civil responsibility owed by all the related subjects within the process of research, manufacturing, circulating and using to the drug victims. The author proposes that drug infringement responsibility be separated into two kinds, one is caused by drug flaw, that is, drug flaw infringement responsibility. The other is infringement responsibility caused by adverse drug reactions. Probe into the imputation principle of drugs'infringement responsibility, drug flaw and responsible subjects. Although drug is different from other products in peculiarity, it's still a product, so drug responsibility theory can also be applied to ordinary product responsibility theory. As a result, this essay makes the product responsibility theory and product flaw theory as an entering point to investigate the drug infringement responsibility and drug flaw. The essence of flaw for ordinary product is"unreasonable danger". Although drug has its peculiarity, the essence of flaw for it is the same. This essay, categorizes drug flaw through the methods of example analysis and contrast, and it expounds different sorts of drug flaw deeply. The author also puts forward some suggestion for the application of law for flawed drug infringement incidents.The fourth chapter"Research on adverse drug reactions"infringement discusses the other kind of drug infringement responsibility, and it also elaborates the relation between untoward effect and flaw of drug. The untoward effect of drug mainly refers to the harmful reaction though drug is used in a right way or just and accident. Drug's untoward effect type is the key point to decide whether infringement responsibility could be charged. To reach a virtual justice, many countries in the world build up a compensating system to redress the torts induced by ADR.As ADR happens more and more frequently in China, while the ADR supervision right now is still at the underway period,we have to learn from the experience abroad, consummating the related legislation.The fifth chapter Conclusion sums up the key points and puts forward some proposal on laws and regulations.