Why didn't the amendment to the drug administration law pass?

On the afternoon of October 26, the sixth session of the Standing Committee of the 13th National People's Congress closed at the Great Hall of the people in Beijing After voting, the meeting adopted 15 laws, including the decision on Amending the criminal procedure law, the newly revised organizational law of the people's court, the newly revised organizational law of the people's Procuratorate, the International Criminal Judicial Assistance Law, the regulations on fire rescue ranks, the decision on Amending the company law and the wildlife protection law The amendment to the drug administration law we are waiting for is not among them! At the sixth session of the Standing Committee of the 13th National People's Congress, the draft amendment to the drug administration law was reviewed in groups on the 26th Participants said that it is necessary and timely for the draft amendment of the drug administration law to adhere to the problem orientation and respond to social concerns Li Rui said According to the outstanding problems existing in the drug management, the revised draft revised some articles and added relevant contents, further strengthened the safety consciousness, responsibility consciousness and social consciousness of the legal representative and the main responsible person of the drug production and marketing enterprise, tightened the responsibilities of the drug regulatory department, improved the drug regulatory mechanism and system, and increased The punishment of illegal drug production and marketing has blocked the regulatory loopholes in the research, development, production and sales of drugs with the system With regard to the responsibilities of the holders of drug marketing licenses in the whole process of drug development, Wu Heng suggested that the full responsibilities of the holders should be further decomposed to clarify the responsibilities in some links of the whole process of drug development, production, marketing and use Councilor Pang Lijuan suggested to establish a system of preliminary examination of drugs and a system of lifelong responsibility or investigation for drug approval Strengthen the awareness of "drug safety responsibility is more important than Mount Tai" of relevant drug review and approval departments, and implement it In addition, we should further study and effectively increase the deterrence and punishment of illegal acts Now, the draft amendment still stays at the level of fine and administrative penalty The cost of violating the law is low, which is not enough to play the role of internal control, deterrence and deterrent Han Xiaowu said that it is important to establish a team of professional drug inspectors in the revised draft However, the current regulations are still relatively principled and difficult to implement It is suggested to further enhance the operability Drug supervision is very professional, different from the supervision of general commodities, it is necessary to clarify the requirements of team building at the legal level, and relevant departments should also strengthen the implementation after the introduction of the revised draft Wu said five new articles were added to the draft amendment that directly mentioned vaccines, including vaccine production license, introduction of information technology, implementation of compulsory insurance, production suspension report and punishment These increases are necessary But for vaccine, which is a kind of special drug, it is not enough to supplement the above regulations, which can not fully reflect the special functions of vaccine and the special phenomena involved It is suggested that there should be clear space for the formulation of relevant laws on vaccines in the draft amendment, and a paragraph should be added in Article 2 As a special drug, vaccines should comply with relevant laws and regulations Gu Xiaoyu said that focusing on the outstanding problems exposed by the problematic vaccines, the implementation of the drug marketing license holder system and the promotion of the reform of the approval system were revised to respond to social concerns in a timely manner Vice chairman Chen Zhu said, The drug problem is a major issue of people's livelihood and public safety It is suggested to further improve the public communication mechanism for drug safety events: once a major drug safety event occurs, the drug regulatory department, together with the health and Health Commission, the Ministry of public security and other relevant units, should inform the public of the problem, the degree and scope of risk, and how to control the situation at the first time, so as to ensure timely stability People's mind, guide public opinion, take it easy Commissioner Congbin said that the draft amendment did not involve the control of the drug price system In the field of drug circulation, the problems of corruption, kickback, and prescription opening, in the final analysis, are that there is too much room for drug retail price The most strict management system should be embodied in price management, and it is suggested that the price control be included in the revised draft Du Yubo said that the draft amendment reflects the whole process of supervision, clarifies the regulatory responsibilities of governments at all levels, and makes clear provisions to solve the problem of low illegal cost However, the revision and improvement of drug administration law need to be considered as a whole Some contents and problems can be included in the next comprehensive revision of drug administration law.