commiss decis octob suspend examin procedur obstacl trade pharmaceut product market republ korea notifi document number ec commiss european commun regard treati establish european commun regard council regul ec decemb lai commun procedur field common commerci polici order ensur exercis commun right intern trade rule establish auspic world trade organis amend regul ec articl thereof consult advisori committe procedur background june efpia european feder pharmaceut industri associ lodg complaint articl council regul ec hereinaft regul behalf member interest market product korea complain alleg commun sale pharmaceut product korea hinder number obstacl trade mean articl regul quot practic adopt maintain countri respect intern trade rule establish action quot alleg obstacl trade discrimin price reimburs practic excess regulatori requir intellectu properti issu complain claim gener lack transpar korean regulatori system time complaint logd korean regulatori system govern pharmaceut undergo period chang made difficult assess suffici evid complaint exist wto violat respect issu commiss decid complaint contain suffici evid justifi initi examin procedur ground discrimin price reimburs practic order make proper assess legal regulatori environ commiss decid account inform discov investig relat issu rais complaint notic publish offici journal european commun reaction korean govern initi examin procedur initi investig note verbal korean author request respond questionnair alleg barrier trade pharmaceut product korean govern repli note verbal inform commiss plan korean legisl govern pharmaceut sector concern issu contain efpia complaint find investig price reimburs issu complaint alleg discrimin foreign product method determin reimburs price system reimburs rule introduc investig elimin discriminatori element previous exist import product admit time list reimburs pharmaceut pharmaceut product elig reimburs state health care system juli import product reimburs rule domest product unfavour treatment innov product remov rule price calcul agre task forc price novemb korean author introduc actual transact price atp system reimburs pharmaceut product intend elimin discount previous demand purchas pharmaceut repres problem intern industri claim domest produc advantag product reimburs price level allow offer substanti discount system includ introduct complex electron data exchang system issu reimburs actual transact price price innov product rule enter forc recent fulli implement regulatori requir rule clinic trial newli market product enter forc januari regul govern market pharmaceut abolish oblig carri clinic trial korea maintain requir applic submit call bridg studi data obtain korean legisl lack detail circumst bridg studi consid suffici leav industri concern requir carri clinic trial korea product regulatori issu possibiltii foreign produc subcontract product local manufactur transfer product licenc rule introduc januari compani manufactur licenc korea violat wto rule found issu intellectu properti issu data protect appear system guarante full protect data submit obtain market authoris case unfair confidenti data report context investig issu patent term restor chang rule clinic trial account latest amend regul patent term extens text medicin develop abroad exempt clinic trial korea extens period includ period spent clinic trial abroad time kfda examin file give approv medicin remov scope discrimin foreign product transpar true easi industri spot understand latest regul govern matter due continu develop system difficulti translat technic matter legisl govern system publish gener made recommend commiss consid system rule pharmaceut product korea undergon substanti chang lodg complaint regul improv possibl commun industri enter korean market legisl introduc implement indic implement delai legisl interpret trade restrict concern confirm latest develop industri main concern lai implement atp reimburs system investig korean author inform commiss servic full implement atp system complet subsequ korean author state place electron exchang data essenti oper system foreseen report transact price fulli place date greater concern juli plan introduct separ prescrib dispens pharmaceut product take place approxim pharmaci requir report price pharmaceut delai introduct electron report system make accur assess price place commiss consid monitor effect korean legisl period month date entri forc decis fulli introduc introduc monitor give indic fact improv situat regard barrier trade pharmaceut product korea alleg complaint examin procedur korean regim govern pharmaceut sector suspend commiss supervis situat accord articl regul report enforc regul issu month date suspens action propos basi report decid sole articl examin procedur obstacl trade pharmaceut product market republ korea suspend brussel octob commiss pascal lami member commiss oj oj oj