The Relief Road To The Harm Caused By Adverse Drug Reactions From The Perspective Of Comparative Law

Drug is a special product, while in the cure of disease, it also brings harm to people because of its risk. Under the modern industrial model, the risk of drugs is undergoing an unprecedented proliferation. In the20th century, lots of large-scale injury incidents had befallen in many countries. Germany’s "thalidomide incident", the United States "DES incident", Japan’s "SMON disease storm" and a series of other tragedies were shocked. With the constant development of pharmaceutical industry and imports of drugs, adverse events of drugs are also increasingly apparent in China. In2000, the "PPA Event" due to the PPA in the common cold medicine caused stroke. In2001, the cardiovascular drug Baycol produced by the German company Bayer caused rhabdomyolysis syndrome and acute renal failure events. In2003, Longdanxiegan pills event occurred. No country could stay aloof because of the adverse drug reactions harm arising from its natural risks. What we have to do is how to better prevent and how to implement adequate relief for victims.Reactions and relief mechanism coping with adverse drug harm is not perfect in our country. Administrative interventions only stay on access and control to the information of adverse drug reactions, not related to the issue of compensation for victims. In the field of justice, because " Product liability law "," Medical Malpractice"," Tort Liability Act " and other laws excluded adverse reactions caused by drugs damages, the victims are walking with difficulty on the road leading to struggling litigation. Since there is no clear legal provisions, judicial precedents are manifold, sometimes the court dismissed the claims because there are no laws, or pursuant to the principle of fairness, or judgment of a certain amount of compensation, but no fundamentally relief for victims.Considerable portion of Chinese scholars have focused adverse drug reactions events, and think about the issues of how to relief the victims. Based on a large number of arguments, this paper tries to seek a viable remedy road to adverse effects of drugs at the present stage in our country. From the text of the definition of adverse drug reactions, starting with the difference between similar concepts, this paper analyzes the legal characteristics of adverse drug reactions, and the difficulties with the relief of tort law because of its special nature. In this paper, drug adverse reactions legislative regime and relief patterns in several typical countries were investigated. We also analyzed their experience and lessons for reference.We should establish a diversified relief mechanism to respond the adverse drug reactions harm, which is currently the consensus reached by scholars and practitioners. But what kind of model of relief mechanism we should establish is a matter of opinion. By comparing pros and cons of the three remedies:tort law, liability insurance and fund relief, this paper demonstrates the feasibility analysis of the current two prevailing views which are to modify imputation principles of tort law and to establish relief model based on liability insurance. Finally, the author constructs a relief road of a pyramid model, which is a unified system formed with reparation for damages in tort as the spire, fund relief system as taki and a variety of remedies complementing each other. In the framework of tort law, the author proposes internal improvement suggestions on the tort law, including the improvement of the identified standard for drugs deficiencies, the adoption of a new theory of causation prove and to strengthen fault accountability for the pharmaceutical companies in violation of the obligation to observe the drug safety in order to give full play to the discipline and motivation function of the tort law. For the construction of the funds system, this paper individually conceives from the following four aspects which are setting up a separate fund legislative, institutional, scope and standards for compensation and fund raising. I hope this could provide some useful exploration for the construction of the relief mechanism to ADR in our country.