Study On The Legal Problems Of Adverse Drug Reaction In China

Drugs are like double-edged swords. They do not only prevent or cure diseases, but also bring potential risks in the meantime. Adverse drug reaction (ADR) is one of the most serious problems, which is closely related to health. It has been raised more and more attention to in public. How to control its negative effects, implement effective supervision to maximize the utility of drugs and reduce the risk have become substantial social problems. As matter stands, the legislation of ADR supervision in China has been well-considered. ADR monitoring system has been basically established, and the regulators’management of ADR has been more reasonable and effective. However, problems in the works of supervision still exist as below:First, the laws of monitoring in China still has much space to improve, which mainly reflects in the low level of laws and regulations of supervision, the lack of operability, the absence of supporting laws and regulations, and the imperfection of post-mortem regulatory legislation on ADR. Second, the supervision mode remains to be imperfect. Is has been dominated mostly by restrictive practices, for example, administrative penalty, which is lack of incentive measures. In this way, regulators become over-dependent on administrative command and control, and objects of supervision lack motivations to actively cooperate with the supervision. On the other hand, supervision of athletic style after events has been especially prominent. The supervision of ADR has always been carried out after major drug safety accidents. The rationality of these major inspections and readjustments are questionable. Third, the adverse drug reaction monitoring is lack of justice independence. The drug administration department has been affected by the local government and the regulatory capture from drug companies, which leads to the incapability of independent justice and supervision. Fourth, administration departments of ADR are lack of internal mechanism of supervision and restraint, mainly for the lack of the accountability of regulators, the unclear information of supervision, and the lack of the performance evaluation system of supervision.In order to solve the existing problems of adverse drug reaction monitoring, cooperation and improvement are necessarily needed in the areas of the regulatory legislation, the choice of the supervision model, and the external independence and the internal restriction of supervision. To improve the regulatory legislation on ADR in China, the level of supervision laws and regulations need to be raised up. Relevant rules or laws should be established. The binding force and operability of laws should be increased, the legislation of relief on ADR in China should be strengthened to provide timely and effective relief to victims, and to function ex post supervision. As to the choice of the supervision mode, on purpose of rationalizing the supervision mode, incentive and restriction should be used simultaneously, and reward and punishment mechanism should be established. Implement the dynamic supervision from the source to the drug market; combine the prevention, supervision and relief judiciously. In the matter of strengthening the external independence of supervision, measures, such as administrative accountability and anti-corruption by considerably increasing income, should be adopted. The drug administration department is not only independent of the local government to prevent improper intervention, but also independent of the objects of supervision to prevent the regulatory capture. At last, the internal restriction of supervision departments and the level of supervision should be improved by establishing the accountability mechanisms of regulators, the public supervision mechanism, the performance evaluation mechanism of supervision.