Health: drug safety blacklist don't become "no tooth tiger."

ZhangFengYi (for civil servants)

Sources: health

        15,, the state food and drug supervision bureau issued the drug safety blacklist management regulations (try out) ", for a serious breach of drugs, medical equipment management laws, regulations and rules are subjected to administrative penalty production operator and its responsible for relevant information, will through the government website, accept social supervision, and the emphasis on the supervision on the implementation. Since 2012 the provisions on October 1,. (August 16,, the Beijing news)

        Food and drug safety events in recent years frequent present situation, last year the national received adverse drug reaction/incident report quantity of 852800, up 23.08%, this year's "poison capsule" event is make social shock. For drugs, medical devices field serious illegal behavior, the establishment of drug safety blacklist, urge and warning production operators to perform comprehensive quality safety responsibility, enhance the whole society supervision and resultant force, without doubt is worth looking forward to.

        However, any black list is not a "black" spirit, and the effect of good or bad depends on the strength of weak sanctions. Compared with the public expect, drug safety blacklist system more like a "no tooth tiger". From the release of the regulations to see, be included in the list of 7 kinds of behavior, in addition to the "in the relevant administrative licensing application process to hide the relevant circumstances or provides false materials," "take other deception, bribery and unfair means, obtain the relevant administrative licensing, approval documents or other qualified" and "the production and sales of fake and inferior drugs if the circumstances are serious production and sales of" three kinds of situations, within a prescribed time limit shall not apply for administrative permission, engaged in pharmaceutical production and business operation activities of the regulation, the rest of the behavior are not substantial punishment. While the existing "increase inspection and sample frequency, shall be ordered to periodic report quality management", etc., it is pointless.

        At the same time, the effect of exposure to the society also is very limited. After all, spittle planetesimals drown, to the blacklist list in terms of their skin early didn't moral blood, it is not afraid to be condemned. Moreover, among the blacklist, common people is impossible to remember, the more impossible went to a chemist's shop to buy medicine, but must take online printed blacklist round screening. More importantly, the public for no medicine enterprises lack of binding. If some enterprise to blacklist fearless, and even put a pair a dead pig fears not scalding water attitude, or change the ma3 jia3, registered a new company was back to the drawing board, it is difficult to avoid the problem of public life and property drug threat.

        Want to drug safety blacklist "tiger punches", you must give it a pair of steel teeth, set up a series of perfect supervision and restraint mechanism. For the list, according to the seriousness of the case, the corresponding to the emphasis on the supervision on the, deadline shutout, lifelong to forbid into the penalty, etc. At the same time, in recent years the drug quality incident exposed fine punishment is not strong enough, the risk of damage compensation relief channel is not smooth, black list system might as well make full consideration, perfect the supervision, loopholes, enhance deterrent force.

        Be worth what carry is, previous draft was put forward, and drug safety blacklist bulletin the hair change, taxation, industry and commerce, finance and other departments, for the industrial planning implementation, bidding procurement, administrative examination and approval, import and export management, financial credit and other related decision-making reference. But in the official launch, this is a law to be deleted, it have to say it's a kind of regret. Blacklist resource sharing, the establishment of mass prevention and mass treatment mechanism, coordination between departments may exist the difficulty, but improve the violation cost, a big silver bullet. Suggest the government department coordination, through the top design promote blacklist drug safety in a wide area power play.

        Finally, drug list cannot be "light black", only to illegal enterprises, let the dereliction of duty regulators stay, some departments power rent-seeking is also an important hand slap drug mess. Let the dereliction of duty, malfeasance personnel problems and punishment also BaoBaoGuang, helps to strengthen the effect of governing revolution blacklist, DaoBi functional departments to the role of gatekeeper.