Study On An Adverse Drug Reaction (ADR)-Related Damage Relief System In China

Medicines are intimately related to human health and provide a second-line protection against diseases. Nevertheless, medicines, when used for the treatment of diseases, also cause some adverse responses--- adverse drug reactions (ADRs). ADRs are dictated by the nature of a drug and, due to the limitations of medical sciences, are practically inevitable.With the development of medical sciences in China, new drugs have been developed steadily and put into clinical practice. On the other hand, lawsuits involving ADRs-related damages have been on rise over the past decades. Since no systemic laws and regulations concerning the ADRs-related damages are in place in China, when dealing with such cases, related laws that might apply have to be invoked. However, these laws, in many cases, failed to definitely define the defects of drugs. Legal practice has shown that this will put the victims of ADRs in an unfavorable position. Moreover, in the cases of ADRs, the party causing the damages is without liability and their behaviors are not illegal. It has been controversial if the victims have to take the full responsibility of the damages. From the perspective of drug producers, they are under too much pressure to be held accountable for the ADRs-related damages, which will dampen the incentives of drug manufacturers in their research and development of new medicines and the medical and pharmaceutical sciences in our country will suffer.This paper believes that the best solution is to establish an ADR relief system. From the perspective of guarding the rights and interests of ADR victims, promoting the pharmaceutical industry, protecting the overall interests of the whole society at large, this paper, by comparing the different theories and practices in other developed countries, designed an ADR relief system that takes into account the context of China. This ARD relief system, based on the legislation, application of relief funds and other details, mainly consists of the finding of drug defects, liability without fault, presumption of causality, selection of relief fund modes, relief money etc. The novelty of the paper lies in that a new ADR relief system that accommodates the conditions of China is designed, and the system includes the perfection of legal relief system and establishment of relief fund modes.