On Drug Liability System

Drug is a kind of special product. Its specialty lies in its risks to those users. In order to ensure the safety of usage, most countries in the world have strictly regulated the manufacture and sales of drugs through legislation. Although this, some accidents brought by the defective drugs which cause damages to victims always happen. When damages occur, how to determine the liability of person responsible and how to give remedy to sufferer, which always become the focus of the legislations in most countries. For example, Germany formulated the special law on Drug Liability in 1978, in Japan there are Law on Manufactured Goods Liability and Remedy System for side effect of drugs, through which those suffers can be well protected. Taiwan area of our country also drafted Law on Remedy to pharmaceutical damage.Starting with the determination of concepts of drug and drug liability, with reference to legal precedents and legislations on defective drugs which cause damages to victims in Germany, Japan and U.S.A, this paper has made a detailed study on constitutive elements of drug liability and system of compensation for damage. The emphasizes of study focus on such aspects as the judgment of defects of drugs, kinds of damage, causation, subjects liable and immunities for liability. On the basis of this, this paper analyzes the puzzles of application of law in practice of drug liability in our country, puts forward the related legislative suggestions, expecting to provide some useful reference to guarantee of lawful benefits of sufferers and construct the legal system of drug liability in our country.