黑名单规定成一纸空文 Blacklist provisions into words

　　由国家食品药品监督管理局制定的《药品安全“黑名单”管理规定(试行)》(下称“规定”)几成空文。规定下发两月有余，全国部分省级以上药监部门虽在其政务网站设置了“违法药品公告栏”，但无一依规在网站主页设置药品“黑名单”专栏。　

By the state food and drug administration of the set[Drug safety"blacklist"Management regulations(trial)](Hereinafter referred to as"provisions")Several into KongWen.Regulations issued by more than two months,The national part department at or above the provincial level is also in its government website set up"Illegal drugs bulletin board",But none in gauge in the website home page setup drugs"blacklist"column.

无一相关部门严格执行新规 All relevant departments strictly implement the new gauge

　　今年10月1日，国家食药监局下发上述管理规定，目的在于进一步加强药品和医疗器械安全监督管理，完善行业禁入和退出机制。根据规定，省级以上食品药品监督管理部门应当在其政务网站主页的醒目位置设置“药品安全‘黑名单’专栏”，将本行政区域内符合条件的违法生产经营者、责任人员纳入药品安全“黑名单”，并由专人管理及时更新。“然而该规定实施2个月之后，各地执行情况却令人失望。”长期关注药品安全的公益人士李英杰说。据其调查，在33个省级药监部门政务网站中，32个政务网站主页均未设置“药品安全‘黑名单’专栏”，而西藏自治区食品药品监督管理局更是连政务网站也没有。“建立药品黑名单栏目是公布黑名单的前提，然而全国竟然无一省级药监部门网站按照规定设置该栏目，国家药监局的规定基本上成为了一纸空文，消费者的知情权根本无法得到有效保障，又何谈保护消费者的身体健康权呢？”李英杰说。

October 1,National food administration issued the above regulations,Purpose is to further strengthen drugs and medical devices safety supervision and management,Perfect industry stands and withdrawing mechanism.According to the regulation,The food and drug supervision and administration at or above the provincial level shall be in the department of government web site home page the conspicuous"Drug safety‘blacklist’column",Within their respective administrative areas will meet the conditions of the illegal production operators/Responsible for into the drug safety"blacklist",And designate personnel management update."Yet the implementation of the provisions of the 2 months later,All implementation but disappointing."Long-term focus on drug safety LiYingJie said public people.According to the survey,At 33 provincial government departments also site,32 government web site home page were not set"Drug safety‘blacklist’column",And the Tibet autonomous region food and drug administration is even the government website also have no."Establish the blacklist column published is the premise of the blacklist,But there was the provincial department in accordance with the regulations also website set up this column,The provisions of the state, the administration's basically become the words,Consumers' right to know can't get effective guarantee,And talk about how to protect consumers' body and health "?"LiYingJie said.

信息披露制度存诸多漏洞 Information disclosure system with many holes

　　同时，李英杰还对这些政务网站发布违法药品信息的情况进行了简单的调查，结果同样不容乐观。根据调查，在32个政务网站主页中，只有16个政务网站主页设置有药品安全信息的专栏，且没有一个专栏提供的信息能够让消费者及时、有效的获取信息。

At the same time,LiYingJie on the government website illegal drug information on the simple survey,The results also is not optimistic.According to investigation,In 32 government web site home page,Only 16 government web site home page setup have drug safety information column,And without a column to provide information to let the consumer timely/Effective access to information.

　　李英杰对16个专栏进行简单统计后发现，有5个网站的专栏信息更新严重滞后，有7个过于简单，有3个徒有虚名——无任何药品安全信息，甚至还有1个网站的专栏完全转载外地违法药品信息。“这些网站既没有设置药品黑名单专栏，也没有其他的有效途径及时公布更新违法药品信息，如何能起到警示作用？这不是变相鼓励药品生产经营者违法吗？”李英杰说。

LiYingJie to 16 column after simple statistics found,There are five website column information update the serious lag,Seven is too simple,There are three nominal - without any drug safety information,Even a website column completely transfer field illegal drug information."The website is not set drug blacklist column,No other effective way by timely update the illegal drug information,How can have the warning role?This is not disguised encourage pharmaceutical production operators illegal?"LiYingJie said.

公益人士致信国家药监局： The administration's national public people wrote a letter:

增加问责条款保证实施 Increase accountability terms to ensure a successful implementation

　　昨日，李英杰通过EMS致信国家食品药品监督管理局，建议国家药监局严格执行药品安全“黑名单”管理规定(试行)，完善违法药品信息披露制度，保障消费者的用药安全。

yesterday,LiYingJie through EMS written state food and drug administration,Strict implementation of the administration's advice national drug safety"blacklist"Management regulations(trial),Perfect the information disclosure system of illegal drugs,Consumer protection safe drug use.

　　信中建议国家药监局尽快按照规定在政务网站主页设立“药品安全‘黑名单’专栏”并且督促各省、自治区、直辖市食品药品监督管理局(药品监督管理局)，新疆生产建设兵团食品药品监督管理局依照规定采取同样的措施，尽快建立起药品安全黑名单的公布渠道。

Believe that the administration's country as soon as possible in accordance with the provisions set up government web site home page"Drug safety‘blacklist’column"And supervise and urge the provinces/Autonomous region/Municipalities directly under the food and drug administration(Drug administration),Xinjiang production and construction corps food and drug supervision and administration in accordance with the provisions of the measures to do the same,As soon as possible establish drug safety announcement channel list.

　　除此之外，建议对该规定进行修改，增加问责条款以保证规定顺利实施，例如可以将第十五条修改为“食品药品监督管理部门及其工作人员违反本规定未在政务网站主页设置药品黑名单专栏、滥用职权、徇私舞弊、玩忽职守的，由监察机关或者任免机关依法对其主要负责人、直接负责的主管人员和其他直接责任人员给予处分。”

In addition,Suggestions to the rules of change,Increase accountability terms to ensure smooth implementation regulations,Such as can be amended as article 15"The food and drug supervision and administration departments and their staff in violation of these provisions not in government affairs website homepage Settings drug blacklist column/Abuse of power/Engages in malpractices for personal gain/derelict,By the supervisory organ or the appointment and removal of the authorities according to law over the main person in charge/Persons who are directly in charge and other directly liable persons shall be punished."

药品安全 离不开黑名单 Drug safety cannot leave the blacklist

　　长期关注食品药品安全的公益机构“南京天下公机构”执行主任程渊认为，药品黑名单的设置及公布能够极大的震慑不法单位及人员，督促和警示生产经营者全面履行质量安全责任，而社会公众也可以很容易通过黑名单了解药品安全的情况避免受到伤害，对于维护药品市场秩序、维护公众的身体健康和安全至关重要，维护药品安全需要这样一个“黑名单”，这也符合国家发改委关于进一步加强药品安全信用体系建设工作的指导意见的精神，既然国家药监局已经做出了规定，就应该带头执行，并且严格监督下级单位执行。

Long-term focus on food and drug safety of public institutions"Nanjing public institutions all over the world"The executive director ChengYuan think,Drug blacklist setting and announced to great deter illegal units and personnel,Supervise and warning production operators to perform comprehensive quality safety responsibility,And the social public can easily through the list to understand the situation of drug safety avoid injuries,To maintain the order of the pharmaceutical market/Maintain public health and safety is very important,Maintenance and drug safety need such a"blacklist",It also conforms to the national development and reform commission on further strengthening and drug safety credit system construction work of the spirit of the guiding opinions,Since the country's drug watchdog has made the rules,You should lead the implementation,And strict supervision of the lower unit execution.

　　公益律师姬来松表示，药品安全黑名单对于维护药品安全的重要性不言而喻，如果调查属实，全国无一省级药监部门按照规定设置药品黑名单栏目，结果不免令公众失望。依法行政是对行政部门的基本要求，依法行政包含的重要一点就是有法必依，省级药监部门的行为将极大的损害政府部门的公信力，因此建议国家药监局尽快督促省级药监部门执行规定，并且追究相关责任人员的行政责任。(记者 陈学超)

Pro bono lawyers to loose her said,Drug safety blacklist for maintenance drug safety importance is self-evident,If the true,The department at the provincial level there also in accordance with the regulations set drug blacklist columns,The results not make public disappointment.Administration according to law is the basic requirements of the administrative department,Administration according to law contains the important thing is to abide by the laws,The provincial department also will greatly damage the behavior of the government credibility,We therefore suggest that countries as soon as possible, the administration's urged provincial also departments to carry out regulation,And the related liable persons shall be investigated for administrative responsibility.(Reporter ChenXueChao)