Legal Control And Indemnity On Adverse Drug Reaction

In 21st century, large-scale accidents of Adverse Drug Reaction happen high frequently, and cause more damages to society than before. People pay more and more attention to this serious problem. Adverse Drug Reaction means that drug even in proper directions for use dosage can cause unrelated reaction with the aim of the pharmaceuticals, or accidental adverse reaction. It is impossible that absolutely safe drug exist in the current world according to present-day technological and scientific development. It is coexisting for drug that adverse reaction and diagnostic, treatment and preventive utility. It unavoidably takes place that adverse reaction of drug. It is very difficult for producers to predict the adverse reaction, so they have no fault liability to the damage. At the same time the injured parties have no fault liability. Who have to take responsibility to damage? There are no relevant laws and regulations to stipulate how to remedy the damage in China now at present. Fault principle in traditional tort law can not be applied to these cases when producers and the injured parties are not both in error. Because the principle of liability without fault is only applied to the cases which have been stipulated in laws, the injured parties in drug adverse reaction have no means to ask compensation according to current laws. It is a big controversial issue whether and how to indemnify these injured parties. In 60 times last century, adverse reaction had become an outstanding problem in German, US and Japan, etc. western developed countries. Aforesaid countries and Taiwan have developed a set of matured and perfect systems to indemnify the injured parties who are damaged by the adverse drug reaction through many years'research and practice.According to research concerned materials, such as cases and legislations, this paper introduces the legislations and indemnity systems of these countries on one hand. On the other hand, it makes a conclusion of general principles, key issue and indemnity systems of drug adverse reaction by comparing different countries'legislations. Although many countries have different legal indemnity model, they all stipulate to indemnify the injured parties with the liability without fault. In the globalization trend, we shall stipulate the principle of the liability without fault to resolve these cases and establish a set of systems and legislations to give the injured party the legal relief. So this paper makes suggestions and designs about liability and indemnity systems of adverse drug reaction in China.On the basis of the rule of law, which is the fundamental policy of the country, we have stipulated and promulgated"the Drug Administration law"and then"the Regulation of Report and Inspection Administration of Pharmaceutical Adverse Reaction". But in practice, all the regulations have been not strictly executed. Whereas it is difficult to avoid the adverse reaction in medical treatment, we can control the negative result of adverse reaction and prevent this negative influence to expand. How to prevent the adverse reaction is the same important as how to relieve the injured parties by legal process. If competent authorities could execute the laws and regulations, many patients would not been victims of adverse drug reaction. Therefore, it is a issue of this paper how to control the adverse drug reaction by rigorously administration and inspection.