药品电子监管的行政法省察

发布时间：2018-03-04 14:03

本文选题：药品电子监管　切入点：行政法省察　出处：《江西财经大学》2014年硕士论文　论文类型：学位论文

【摘要】：药品电子监管实质上就是监管部门行使行政权力,药品电子监管的实施过程就是权力行使的过程。监管部门行使行政权力应当以法律、法规为前提,也就是说监管部门应当在法律、法规有明确规定的前提下实施监管权力。并且,行使监管权力还必须具有维护公共利益目的,监管部门行使药品监管权力应以保障药品安全为目的。同时,在监管权力行使过程中需要遵循相应程序,听证程序和信息公开程序是必不可少的程序。行使行政权力还需要注重行政效率问题,以最少的行政成本达到最好的行政效果。从法律、法规依据来看,监管部门推行药品电子监管的法律、法规依据是不足的。现有《药品管理法》及其实施条例等法律、法规中均未授权国家食品药品监督管理局推行该制度,其他关于药品管理的法律、法规中也未有相关规定。当具体监管手段涉及行政相对人具体权利义务时,该种手段应当有法律、法规上的依据。从实施手段来看,监管部门运用行政命令手段实施药品电子监管也是不妥的。监管部门在没有相应程序规范下不能运用国家强制力推行药品电子监管,促使药品生产、销售企业不得不开展药品电子监管工作。此次实行药品电子监管制度在没有充分法律依据的前提下就以行政命令形式予以推广,该行为很难让行政相对人积极配合。进而行政主管机关对不配合的相对人进行执法,会导致行政执法成本大大增加,并且也不能达到公共利益所追求的目标。从法律目的来看,药品电子监管最主要也是最核心的目的就是监管药品安全,保障公众用药安全。由于药品电子监管存在技术上、法律上和实施过程中的问题,导致公众难以准确、及时地查询到药品电子信息,药品监管部门也难以追溯药品流转信息。进而使得药品电子监管核心目的难以达到。因此,就目前实施现状而言,药品电子监管并没有达到法律目的,或者说需要达到目的所需要付出的代价巨大。因此,从行政法的角度来看,当前药品电子监管方式违反了行政法合法性原则和合理性原则以及比例原则,亟需修改完善该制度,确保药品电子监管符合行政法原则和精神。
[Abstract]:In essence, electronic supervision of drugs is the exercise of administrative power by regulatory authorities, and the implementation process of electronic supervision of drugs is the exercise of power. The exercise of administrative powers by regulatory authorities should be based on the premise of laws and regulations. That is to say, the regulatory authority should be implemented on the premise that the laws and regulations have clear provisions. Moreover, the exercise of the supervisory power must also have the purpose of safeguarding the public interest. The purpose of the supervision and control department in exercising drug supervision power should be to ensure the safety of drugs. At the same time, the corresponding procedures should be followed in the process of exercising the supervision power. The procedure of hearing and the procedure of information disclosure are essential procedures. In order to achieve the best administrative effect, it is necessary to pay attention to the problem of administrative efficiency in the exercise of administrative power. Judging from the basis of laws and regulations, the laws and regulations on the electronic supervision of drugs implemented by the regulatory authorities are inadequate. The existing laws such as the Drug Administration Law and its implementation regulations, None of the regulations authorized the State Food and Drug Administration to carry out the system, and there are no relevant provisions in other laws and regulations on drug administration. When specific regulatory means involve the specific rights and obligations of the administrative counterpart, The means should have legal and regulatory basis. From the point of view of the means of implementation, it is also inappropriate for the regulatory authorities to implement electronic supervision of drugs by means of administrative orders. Without the corresponding procedures and norms, the regulatory authorities cannot use the state's coercive power to carry out electronic supervision of drugs, thus promoting the production of drugs. Sales enterprises have to carry out electronic drug supervision work. This time, the electronic drug supervision system has been popularized in the form of administrative orders without sufficient legal basis. It is very difficult for the administrative counterpart to cooperate actively with the administrative counterpart, and then the administrative competent authority carries out the law enforcement against the uncooperative counterpart, which will lead to a great increase in the cost of administrative law enforcement, and will not achieve the goal pursued by the public interest. From the legal point of view, the most important and core purpose of electronic supervision of drugs is to supervise drug safety and ensure the safety of drug use by the public. Because of the technical, legal and implementation problems in electronic supervision of drugs, As a result, it is difficult for the public to accurately and timely query the electronic information on drugs, and it is difficult for the drug supervision department to trace back the information on the circulation of drugs. Thus, it is difficult to achieve the core goal of electronic supervision of drugs. Therefore, as far as the current implementation situation is concerned, Electronic drug regulation does not achieve the legal purpose, or need to achieve the end of the cost. Therefore, from the angle of administrative law, the current mode of electronic supervision of drugs violates the principle of legality, rationality and proportionality of administrative law. It is urgent to modify and perfect the system to ensure that electronic supervision of drugs conforms to the principles and spirit of administrative law.
【学位授予单位】：江西财经大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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