Thedirectrelationshipbetweenvaccinesandpublichealthmeansthattheproduction,transport,sale,managementanduseofsuchmedicinesareofmajorconcerntothepublic.PresidentXiJinpingdemandedthatthecasebecarefullyinvestigatedandanywrongdoingbeseverelypunished.PremierLiKeqiangalsocalledforathoroughinvestigationintotheentireprocessofvaccineproductionandsales.
Despitetherecentincident,Chinaundertakesstrictmanagementofvaccinesandhasawell-developedsystemfortheirproductionandsale.VaccineproducersarerequiredtoadheretotherulesandregulationssetoutintheDrugAdministrationLawofthePeople鈥檚RepublicofChina(DALPRC)andtheGoodManufacturePracticeofMedicalProducts(GMPMP),aswellassubjecttoinspectionbyrelevantwatchdogsatanytime.
TheproblematicvaccineswererevealedbytheChinaFoodandDrugAdministration(CFDA)duringaspotcheckonJuly5.Spotcheckstaketheformofanon-siteinspectionwithoutpriornotification.AccordingtoaCFDAreportissuedonJuly15regardingtheirinspection10daysearlier,Changshengforgedtheproductionrecordsandproducttestingrecordsoffreeze-driedrabiesvaccinesforhumanuseandhaphazardlyalteredtechnologicalparametersandequipment.ThecompanyhasseverelyviolatedtheDALPRCandGMPMP,andproductionhasbeenhalted,itsGoodManufacturingPractices(GMP)Certificaterevokedandallunusedrabiesvaccinesrecalled.
TheChangshengincidentisnottheonlycaseofitskindinrecentyears.Inapreviouscase,flawsinthetransportandmanagementofvaccinesledtoalargenumberofexpiredmedicinesinnorthChina鈥檚ShanxiProvincebeingadministeredtochildren.
WhydoproblemswithvaccinesinChinapersistdespitetheirbeingastrictmanagementsysteminplace?Theanswerliesprimarilywiththehugeprofitsavailableandthecomparativelylightpunishmentforviolationsofthelaw.
Changshengismainlyengagedintheresearch,development,productionandsaleofvaccinesforhumanuse,withthecompany鈥檚annualreportshowingprofitmarginsof86.55percentin2017.Sharpprofitsareaccompaniedbyminorlegalconsequences.InChina,drugcompanies,includingvaccineproducers,needtoabidebyDALPRC,GMPMPandCriminalLaw.OnlywhenanentityisdefinedashavingcommittedacrimeistheCriminalLawinvoked.
AccordingtoArticle141andArticle142ofChina鈥檚CriminalLaw,whoeverproducesorsellsmedicineofinferiorqualitythatcausesseriousharmtohumanhealthwillbesentencedtoprisonforthreeto10yearsandgivenafine.Iftheconsequencesareespeciallyserious,thenimprisonmentisfor10yearstolife,alongwithacorrespondingfine.
Ifproductsaretreatedasdrugsofinferiorquality,thehighestfinesarenomorethanthreetimesthesumobtainedthroughtheirsale.
ThevaccinesproducedbyChangshengarenotabletobedefinedasfakeaccordingtocurrentregulations.Officialreportsshowthattherabiesvaccinesthemselveswerenotproblematic,butshouldbeconsideredmedicineofinferiorqualityinstead.Itisthussofarunclearwhatkindofpunishmentwillbefallthecompany.
AsChinesesocietybecomesincreasinglysensitivetoissuesconcerningpublichealth,theimmoralandrecklessbehaviorofChangshenghascausedpublicuproar.TheChineseGovernmentisintheprocessofupdatingitsresponsetosuchincidents,breakingawayfromtheoldpracticecenteredonfines,whilethepolicehavealreadyfiledacaseagainstthecompanybosses.
Whenitcomestomattersrelatedtohealth,regulatorsandlawenforcersmustbefirmintheirresponsebyimposingstrictpunishments.OnlyinthiswaycanChinaeffectivelystampoutsuchincidentsandproperlyfulfillitsresponsibilitytothepeople.
Whenitcomestomattersrelatedtohealth,regulatorsandlawenforcersmustbefirmintheirresponsebyimposingstrictpunishments
CopyeditedbyLaurenceCoultonCommentsto