CNDSN January 9th news [] (CBN) has nearly three drug application was "shot" in the examination and approval links every year, in 2014 as an example, chemicals, medicine, biological agents concluded about 1900 acceptance number, about 560 is not approved, but after the final wait to be "shot" the results may have been a few years.

在每年几百个被“枪毙”的申请中，2011年开始，越南一家名为VELLPHARM的药厂（下称“越南药厂”）便开始与国家食品药品监督管理总局（下称“食药监总局”）展开了长达3年的诉讼拉锯战，从北京中院到北京高院，最终走到了最高院。

Starting in 2011 of the year hundreds of applications was "shot", in Vietnam, a company called VELLPHARM pharmaceutical factory (hereinafter referred to as "Vietnam pharmaceutical factory") began with the State Food and Drug Administration (hereinafter referred to as "the food and Drug Administration") carried out up to 3 years of litigation seesaw battle, from the Beijing intermediate people's court to the Supreme Court of Beijing, finally come to the court.

让人意外的是，最高院推翻了此前判决，食药监总局败诉。越南药厂董事长贝庆生向《第一财经（微博)日报》记者表示：“只是因为一个不关乎药品安全、质量和有效的原因就将我们的申请‘枪毙’，而且也没通知补充材料，我就是想改变食药监总局这种做事的方式。”

Surprisingly, the Supreme Court overturned the previous decision, the food and Drug Administration lawsuit. The Vietnamese pharmaceutical company chairman Bei Qingsheng to the "First Financial Daily" the reporter (micro-blog) said: "just because one is not a matter of reason and drug safety, quality and efficient will our application 'shoot', but did not inform the supplementary materials, I just want to change the food and Drug Administration this way of doing things."

中国医药企业管理协会会长于明德向本报记者表示，未来只有尽量缩小自由裁量的空间，将规定细化、完善，才能更公平合理。

Chinese pharmaceutical enterprise management association president Yu Mingde expresses to our newspaper reporter, the future only try to narrow the space of discretion, will specify and perfect, can be more fair and reasonable.

“告官”常客

"Official" regulars

这是一场药企版的“秋菊打官司”，一审与二审的结局并不意外，均驳回了贝庆生的诉讼请求，不过，最高院的终审结果却以扭转性的判决让人惊讶。

This is a pharmaceutical company's version of "the story of Qiu Ju", first and second hearing ending is not accidental, were dismissed Bei Qingsheng's claim, however, the final results of the Supreme Court to reverse the verdict was surprising.

贝庆生激动地对记者表示，这几年来，报上去的10多个新药都已经被“枪毙”掉，从2004年成立，越南药厂至今在中国还没有获得一份批文。

Bei Qingsheng excitedly told reporters, in recent years, more than 10 new papers have been "shot down", from its establishment in 2004, the Vietnamese pharmaceutical companies so far in the China has not obtained a permit.

事件源于2009年4月，越南药厂向食药监总局申请注册一款化学药品，到2010年11月，食药监总局以原料药生产没有相关批件为由对此药品作出了不批准注册的决定。

The event source in 2009 April, Vietnam to the food and Drug Administration in pharmaceutical applications for the registration of a chemical, by 2010 November, food and drug administration to raw material medicine production without approval related grounds this drug made the decision of approval of registration.

贝庆生说：“500多天的审批，本来已经超过法定期限，最后‘枪毙’的理由竟然是原料药没有批件，其间也没有通知我们补充材料，重新审批又要再等，太浪费时间。”事实上，无论根据《行政许可法》还是《药品注册管理办法》均规定，应当在20日内作出审批决定，不能决定的可以延长10日。同时管理办法还规定了技术审评新药临床试验的时限是90日。以此计算，结果应该最多在120日内作出决定。

Bei Qingsheng said: "the approval of more than 500 days, already exceeded the legal time limit, finally 'shot' reason unexpectedly is raw material medicine without approval, there is no informed us of supplementary materials, re approval again, it is a waste of time." In fact, no matter according to the "administrative licensing law" or "drug registration management measures" are prescribed, shall make a decision of examination and approval within 20 days, it may extend for 10 days can not decide. At the same time management approach also provides a technical review of new drug clinical test time is 90 days. This calculation, the results should be up to make a decision within 120 days.

“原料药没有批件只是其一。”让贝庆生不能接受的是超时等待之后，得来的“枪毙”结果并不合理，“在这种情况下，换一家原料药制造企业就可以了，一公斤原料药价格高达100~200元，但已经足够生产20万颗药了，并不存在成本问题。而且这款药物属于仿制药，早就在越南上市销售五六年，在中国香港也有销售，药品不存在安全性、有效性、质量可控性的问题。”

"There is only one raw material drug approval." Let Bei Qingsheng can not accept is the timeout after, to "shoot" is unreasonable, "in this case, for an API manufacturing enterprises can, one kilogram of raw material price up to 100~200 yuan, but enough to produce 200000 pills, does not exist the question of cost. But this drug belongs to generics, early in the Vietnam listed for sale in five or six years, China Hongkong also has sales, the drug does not have a safety, effectiveness, quality controllability problems."

其实，这已经不是贝庆生第一次“告官”了，其从事药品行业超过20年，跟全国各地的政府主管部门也打过大大小小几十场官司。早在2003年，贝庆生就曾因对药品定价政策不满，将国家发改委前身国家计委“推”上了法庭，开启了“中国药价第一案”的马拉松；之后在2010年，他又将江苏省卫生厅告上法庭，让医药界的招标过程引起了关注。

In fact, this is not the first time "Bei Qingsheng Gao Guan", which is engaged in the pharmaceutical industry for more than 20 years, the government department in charge of with all parts of the country have played greatly small dozens of lawsuit. As early as in 2003, Bei Qingsheng because of dissatisfaction with the drug pricing policy, the national development and Reform Commission, the State Planning Commission will be the predecessor of "push" on the court, the opening of "the first case of" Chinese prices marathon; then in 2010, he and the health department of Jiangsu Province on the court, let medicine bidding process caused concern.

最高院逆转判决

The court reversed the judgment

这桩“民告官”案件，最值得玩味的是最高院的终审判决。根据最高院的判决，其认为食药监总局没有给予贝庆生补充材料的机会是“没有充分保护申请人的相关合法权益”，属于“裁量不当”。

This pile "mingaoguan" case, the most worth pondering is the final judgment of the Supreme court. According to the court verdict, the food and drug administration that the opportunity has not given the shellfish birthday supplementary material is "not related to the legitimate rights and interests of the applicant" full protection, belonging to the "discretion improperly".

在最高院看来，判断是否需要申请人补充材料属于食药监总局的“自由裁量权”。但是，裁量权的行使应该符合立法目的并有利于维护相对人的合法权益。最高院认为，在通过解释或者补充材料就可以对有争议性的药品是否满足安全性、有效性和质量可控性做出进一步评价的情况下，就不应该以申请人提供的资料欠缺、不充分和不符合要求为由驳回申请。

It seems that in the court, judge whether to need the applicant to provide supplementary materials belongs to the food and Drug Administration "discretion". However, the exercise of discretion should be consistent with the legislative purpose and is conducive to safeguarding the legitimate rights and interests of the relative people. The court thinks, through explanations or supplementary materials can whether meet the controversial drug to make effective and quality controllable safety, further evaluation of the circumstances, it should not be in the information provided by the applicant, the lack of inadequate and do not meet the requirements to apply for by barge.

因此，在贝庆生的这桩案件中，最高院认为，食药监总局不应该直接“枪毙”越南药厂，而是应该要求对方补充材料，再做判断。

Therefore, in this case of Bei Qingsheng, the court thinks, food and drug administration should not be directly "shot" Vietnam pharmaceutical companies, but should ask the other supplementary materials, to do judgment.

Bei Qingsheng said that the "shot" is based on "discretion", is the food and Drug Administration said to calculate, but what is discretionary basis? When can the supplementary materials? When can directly "shot"? Might be a rent-seeking space? He felt very not clear, "in my opinion, all applicants must have supplementary materials, not the food and drug administration that 'necessary' have added the opportunity. The review considers between several safety, effectiveness dimension is not mutual precondition, the food and drug administration can not be simply because no supplementary materials, even the other links are not given the opportunity to review."

显然，食药监总局也关注到最高院对“自由裁量权”的涉及，但他们对此有异议。食药监总局本案的代表律师李江向本报记者表示，药品的审批涉及很强的专业性、技术性问题，不能靠行政审批判断，《药品注册管理办法》规定了“必要时”才发补（指“要求补充资料”），而不是“必须”发补，是否发补由药品注册机构决定，属于自由裁量权，而不属于行政审判要解决的问题，“法院审理的是行政行为的合法性，而不应该涉及行政机构的自由裁量权，如果以这个理由推翻之前的判决，是没有法律依据的。”

Obviously, food and drug administration also paid attention to the court for "discretion" to, but they have objection. Food and Drug Administration in the case of the lawyers representing Li Jiang expresses to our newspaper reporter, examination and approval of drugs to professionalism, strong technology, can not rely on the administrative examination and approval of judgment, "measures" drug registration management provisions of the "necessary" to send repair (refers to the "request for information"), not "must" fill, whether hair complement consists of drug registration mechanism, which belongs to the right of discretion, and not to the administrative trial to solve the problem, "the legitimacy of the court is the administrative behavior, and should not be the discretion of administrative institutions involved, if prior to the overthrow of the reasons for the decision, there is no legal basis."

李江同时向记者强调，有些材料即便发补也补不过来，即便是补了，药品审批的其他问题也足以无法获准注册，因此补是没有必要的，所以管理办法才规定了“必要时”才补，“最高院又依据什么认为必要发补？最高院不应该涉及自由裁量权的。”

Li Jiang emphasizes to the reporter at the same time, some materials even hair complement complement not over, even if is filled, the other problem drug approval also enough not to be allowed to register, so the patch is not necessary, so the management approach to the provisions of the "repair when necessary", "the court on the basis of what think necessary? The court should not be involved in the discretion of the."

对于败诉结果，李江表示：“既然最高院作出判决，我们也接受。”本报记者同时向食药监总局发去采访提纲，咨询其对本案判决的看法，但暂时未收到回复。

For losing the results, Li Jiang said: "since the Supreme Court's judgment, we also accept." Reporter at the same time to the food and Drug Administration sent the interview outline, consulting the views on the ruling, but not yet received a reply.

Discretionary Power

显然，最高院在评判此案时，看重的是食药监总局“自由裁量权”执行的背后。

Obviously, the court in the judgment of the case, is the value of the food and Drug Administration behind "discretion" execution.

在判决书中，最高院特别提到在行使权力的背后，食药监总局应当“尽到善意的提醒义务”，而不是“只要申请人提供的资料不充分或者真实性存疑就可以对其申请作出不予审批的决定”。

In the verdict, the court specifically mentioned behind the exercise of power, food and drug administration should "try to remind obligation", instead of "as long as the information provided by the applicant is not sufficient or of doubtful authenticity can not to the approval of the decision on its application".

一位不愿透露姓名的业内人士接受本报记者采访时表示：“在这件案例中，的确是可以采取补充资料这样的程序，不过当中遇到的问题非常复杂，比如说如何证明原来的原料药与之后更换的原料药效果、质量一模一样，因为提供的所有试验都是由原来的原料药做的，即使补充资料也很难判断安全有效性，所以有时候食药监总局也会基于这点考虑，直接将申请‘枪毙’掉。在这个案件中，双方都有责任。”

A condition of anonymity, said the industry an interview with this reporter: "in this case, is indeed can adopt procedures to add such data, but encountered problem is very complicated, for example how to prove the original raw materials and quality of raw materials after the drug effect, the replacement as like as two peas, because all the tests provide are made of raw material medicine original do, even if additional information is also difficult to judge the effectiveness and safety, so sometimes the food and drug administration also based on this consideration, direct application 'shot' out. In this case, the two sides have a responsibility."

医药魔方相关负责人向本报记者表示，药审本身就通过人审理，肯定会受到人为因素影响，重要的是控制标准。每年药审中心都会组织审评培训班，明确地讲述哪些情况会要求补充资料，哪些情况会直接枪毙，但因为面对的情况太多，这些都无法一一通过条文列举。他并不认同在新的药审制度下，存在明显的寻租空间，“这是大家的特权思维在作怪，好像不送点钱就过不去，是社会的一块心病。”他认为，在这种情况下只有信息越来越公开、透明，才能慢慢解决这个问题。

Pharmaceutical Rubik's cube relevant responsible person said to the reporter, drug trial itself through the human trial, will certainly be affected by human factors, it is important to control the standard. The annual drug trial center will organize the review training class, clearly about what the situation will require additional information, which will direct the shot, but because too many of the situations, these are not one one through the provisions cited. He did not agree on a new drug trial system, there exist obvious rent-seeking space, "this is all privileges thinking in time, if not the money did not go, is a piece of heart disease society." He believes that, in this case only the information more and more open, transparent, to gradually solve the problem.

“药审与商标专利申请这些已经标准化的审核还不一样，它有些东西还不那么清晰。”一位不愿意透露姓名的业内人士表示，“比如在复审阶段，其他成熟的评审体系应该是不同人去复审，但药审中心的人员本身不多，很多时候复审的与前期评审的人员是一样的，这样很容易就会造成对审评的不认同。当然，如果申请人对审评结果不认同，可以与药审中心进行沟通，必要时提请复审。这个渠道是现成的，每年都会有一些药品通过复审而最终获得批准。”

"The drug trial and trademark patent applications for these have been standardized audit is not the same, some things in it is not so clear." A reluctance to disclose the names of the industry said, "such as in the review stage, other mature evaluation system should be different to review, but the center for drug evaluation and personnel itself is not much, a lot of time to review and pre assessment of personnel is the same, so easily cause to review do not agree. Of course, if the applicant does not agree with the evaluation results, can communicate with the center for drug evaluation and, when necessary to review. This channel is available, every year there are some drugs through the review and final approval."

于明德也向记者表示，如果药审也像其他刑事法律一样细致，有一些“自由”就可以缩小了，所以规定要明晰化、具体化，才能逐步缩小自由裁量权的空间；另一方面，审批环节要更公开、透明化，打破“几个人关着门批药”的现状，才能保证药品审批更加合理公正。▲

Yu Mingde also expresses to the reporter, if the drug trial also like other criminal law equally careful, there are some "free" can be reduced, so the regulations must be clear and concrete, to gradually reduce the discretion of space; on the other hand, the examination and approval links to more open, transparent, "few people break the status quo closed group of medicine", in order to ensure the drug approval more fair and reasonable. *

（原标题：民把官告赢 越南药企指中国药监总局审批过程太官僚）

(original title: people put the officer Gaoying Vietnam pharmaceutical companies refers to Chinese Drug Administration approval process too bureaucratic)

责任编辑：婉婉

Editor: Che Wan Wan