On China 's Drug "blacklist" System

In recent years, the rate of illegal acts on drugs and medical devices in ourcountry is constantly at high level. In order to strengthen supervision andmanagement on drugs and medical devices registration, The State Food andDrug Administration (SFDA) issued the Drug Safety Blacklist Management Rules(interim) on August16,2012.From the rule–making subject and practical social effect point of view, Thedrug safety blacklist system do comply with the composition of administrative act,which is more precisely a kind of specific administrative act. However, other thanadministrative penalty the drug safety blacklist system is a new way ofadministration, aiming to subsequently complementary supervision. It is also anact of information publication, which does belong to any present kind ofadministrative act, namely an untyped specific administrative act.The State food and drug administration, which originates from theauthorization of law, has the power to formulate the drug safety blacklist system.As a specific administrative act, the system meets the requirements of thestatutory legality; in the meantime, in case of production and operation of relatedproductors, operators and their main responsible person (s),which violatesprovisions of relevant laws and regulations, they shall be subject tocorresponding legal regulation. Therefore, the administrative act is legal.Administrative acts will inevitably face the problem of infringement of the rightsof the administrative relative person, the administrative relative person can filedall levels of food and drug administration for administrative reconsideration oradministrative litigation.The drug safety blacklist system is conducive to strengthening drug marketregulation, which would promote fair competition and safeguard the interests ofsociety. Meanwhile, the system also has important reference significance tosocialist rule of law construction. Although this system is still in its early stage, itdoes make a lot of sense and needs to be further perfected. Firstly, theregulatory organs should perform their official duties according to law. Secondly, it is necessary to establish a system of national multi-sectoral jointadministration. Thirdly, the food and drug administration at all levels shallactively promote the government information publication about the drug safetyblacklist system. What’s more, the relevant administrative subject shallconsciously accept the supervision of the authorities and Strengthenself-supervision. Last but not least, we should enhance legislative guarantees toensure the credibility of the system. Also, related departments should earnestlyimplement the system.If the drug safety blacklist system is subject to the whole management of thesingle government department SFDA, in the process of running the system,government failure will inevitably appear. However, if this system is completelymanaged by the market subject, market failure will also be an unpleasant result.Therefore, the thesis holds that the social intermediate organizations should beinvolved and play a big role. For instance, consumers’ associations, OfficialNGOs, industry association, etc. When enforing this system,those socialintermediate organizations shall abide by the provisions of The State Food andDrug Administration, and they shall be subject to supervision by The State Foodand Drug Administration at the same time. With all things considered, the drugsafety blacklist system would be built into an accountable, efficiently-running,effectively-regulated safety supervision system and operational mechanism andthe role and value of the system would be brought into full play.