全國人大代表、華海藥業總裁陳保華

　　中(zhong)證(zheng)網訊（記者(zhe) 昝秀麗）全(quan)國(guo)人大代表、華海藥業總裁陳(chen)保華近日在接受中(zhong)國(guo)證(zheng)券報(bao)記者(zhe)采訪時建議(yi)，加快(kuai)建立健全(quan)我國(guo)藥品專(zhuan)利(li)鏈(lian)接制度體系(xi)。

　　“藥(yao)(yao)(yao)(yao)(yao)品(pin)專(zhuan)(zhuan)(zhuan)利鏈(lian)(lian)(lian)接(jie)制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)（或藥(yao)(yao)(yao)(yao)(yao)品(pin)專(zhuan)(zhuan)(zhuan)利糾紛早(zao)期解決(jue)機(ji)制(zhi)(zhi)(zhi)(zhi)(zhi)）,是指將(jiang)藥(yao)(yao)(yao)(yao)(yao)品(pin)上市審批程(cheng)序與藥(yao)(yao)(yao)(yao)(yao)品(pin)專(zhuan)(zhuan)(zhuan)利糾紛解決(jue)程(cheng)序、藥(yao)(yao)(yao)(yao)(yao)品(pin)監管部(bu)門(men)職能與專(zhuan)(zhuan)(zhuan)利管理部(bu)門(men)職能相銜(xian)接(jie)的(de)制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)。”陳(chen)保華(hua)介紹，專(zhuan)(zhuan)(zhuan)利鏈(lian)(lian)(lian)接(jie)制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)是一個綜合性體系，內(nei)含或關聯(lian)著專(zhuan)(zhuan)(zhuan)利期延長(chang)、簡(jian)化(hua)新藥(yao)(yao)(yao)(yao)(yao)申請、專(zhuan)(zhuan)(zhuan)利挑(tiao)戰和首仿(fang)藥(yao)(yao)(yao)(yao)(yao)等系列制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)，是直(zhi)接(jie)關系著專(zhuan)(zhuan)(zhuan)利藥(yao)(yao)(yao)(yao)(yao)產業(ye)(ye)保護、仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)產業(ye)(ye)高質量發展、仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)使(shi)用替代的(de)基礎性、關鍵(jian)性制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)，對(dui)(dui)整個醫藥(yao)(yao)(yao)(yao)(yao)產業(ye)(ye)的(de)發展影響(xiang)巨大。面(mian)對(dui)(dui)老(lao)齡化(hua)日趨(qu)嚴(yan)(yan)重帶來的(de)醫療壓(ya)力，許多發達國(guo)家建立(li)(li)了(le)(le)(le)專(zhuan)(zhuan)(zhuan)利鏈(lian)(lian)(lian)接(jie)制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)，并出臺相關政策(ce)，推進了(le)(le)(le)仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)替代使(shi)用，促進了(le)(le)(le)醫藥(yao)(yao)(yao)(yao)(yao)產業(ye)(ye)發展，取得了(le)(le)(le)顯著成效。我國(guo)是仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)大國(guo)，但是大而(er)不強，主(zhu)要(yao)根(gen)源之一在于(yu)我國(guo)的(de)藥(yao)(yao)(yao)(yao)(yao)品(pin)專(zhuan)(zhuan)(zhuan)利鏈(lian)(lian)(lian)接(jie)制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)建設(she)嚴(yan)(yan)重滯后，制(zhi)(zhi)(zhi)(zhi)(zhi)約了(le)(le)(le)仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)企業(ye)(ye)挑(tiao)戰專(zhuan)(zhuan)(zhuan)利搶首仿(fang)的(de)動(dong)力，進而(er)制(zhi)(zhi)(zhi)(zhi)(zhi)約了(le)(le)(le)我國(guo)仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)產業(ye)(ye)發展和仿(fang)制(zhi)(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)替代。因此，必須(xu)要(yao)深化(hua)相關制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)改革，加快建立(li)(li)健(jian)全我國(guo)的(de)藥(yao)(yao)(yao)(yao)(yao)品(pin)“專(zhuan)(zhuan)(zhuan)利鏈(lian)(lian)(lian)接(jie)”制(zhi)(zhi)(zhi)(zhi)(zhi)度(du)(du)(du)體系。

　　陳保(bao)華(hua)建議，加快修訂健全《中(zhong)國上市藥品(pin)目錄集(ji)》；完善“專利期補償”制(zhi)(zhi)度(du)；完善首仿(fang)藥“市場獨占期”制(zhi)(zhi)度(du)；建立“簡化新藥申請(qing)”制(zhi)(zhi)度(du)；明確(que)規定“首仿(fang)日”和“首仿(fang)者”范圍(wei)；建立專利鏈接(jie)有關機(ji)制(zhi)(zhi)，保(bao)障專利鏈接(jie)制(zhi)(zhi)度(du)的落實；發(fa)揮使(shi)用(yong)環節(jie)的“拉(la)動”和監管環節(jie)的“保(bao)障”促進作用(yong)。