Internal informer of vaccine legislation reacquire

Medical network reported on January 9 that China's first vaccine management legislation has made new progress, and the "vaccine management law (Draft)" (hereinafter referred to as the "draft") which was discussed and adopted by the executive meeting of the State Council has recently launched public opinion Compared with the vaccine management law (Draft for comments) published in November last year (hereinafter referred to as the draft for comments), the draft articles ranged from 100 "slimming" to 88, and increased penalties for illegal acts such as production and sale of fake and inferior vaccines, and increased rewards for internal informants of enterprises It is reported that the draft will be open for comments until February 3, 2019 Progress: more than 100 opinions were received in three days of public solicitation As the first vaccine law in the world and China, the legislative process of vaccine management law has attracted much attention Reporters saw on the website of the National People's Congress that the draft had been discussed and adopted at the executive meeting of the State Council, and solicited public opinions from January 4 to February 3, 2019 As at 1700 hours on 7 January, 133 comments had been received There are 11 chapters and 88 articles in the draft, including general provisions, vaccine development and marketing license, vaccine production and batch issuance, post marketing research and management, vaccine circulation, vaccination, monitoring and compensation for abnormal reactions of vaccination, safeguard measures, supervision and management, legal responsibilities and supplementary provisions The draft is easy to copy On November 11, 2018, the draft for comments drafted by the State Drug Administration and the state health and Health Commission started the half month consultation phase According to the people's Congress of China, after the consultation, the State Administration of market supervision, together with relevant departments, drafted the vaccine management law (Draft for review), which was submitted to the State Council in November 2018
After receiving the draft for examination, the Ministry of justice solicits the opinions of relevant departments, provincial people's governments, some associations and enterprises, goes to the vaccine production enterprises for investigation, holds symposiums to listen to the opinions of vaccine production enterprises, disease prevention and control institutions, vaccination units, local regulatory departments and experts, and on this basis, works with the General Administration of market supervision, the drug administration, the health and Health Commission and other departments to The draft for examination has been studied, coordinated and revised to form the draft Dispute: the compensation standard for adverse reactions of vaccine needs to be clarified Zhang Yi, a legislative participant of vaccine management law and assistant researcher of Tsinghua University School of law, believes that the draft embodies the most rigorous standards, the most stringent supervision, the most severe punishment, and the most serious accountability "four strictest" requirements, and further refines and optimizes after absorbing the opinions of all sectors of society For example, the draft clearly stipulates the strictest national management system for vaccines in the general provisions But many clauses are still controversial For example, there is a heated debate on the compensation mechanism of abnormal vaccination response In short, how to compensate the victims of vaccine adverse reactions Due to individual differences, the recipients may still have serious adverse reactions to cause disability and death after receiving the qualified vaccine according to the standard vaccination procedures, but it is relatively rare The industry defines it as "devil lottery" In reality, due to the different compensation standards and complicated compensation procedures, it is very difficult for the victims to settle their claims After several discussions, the draft still maintains the same provisions as the draft for comments In China, immunization program vaccines (i.e class I vaccines) are free and compulsory, such as polio, measles and other vaccines for children Non immunization program vaccine (i.e class II vaccine) is self funded and voluntary, such as rabies vaccine For those who need compensation for abnormal reactions caused by vaccination of class I vaccine, the draft puts forward that the compensation expenses shall be arranged by the financial department of the people's Government of the province, autonomous region or municipality directly under the central government in the funds for vaccination work; the specific compensation methods shall be formulated by the people's Government of the province, autonomous region or municipality directly under the central government Zhang Yi pointed out that this is likely to cause huge differences in compensation standards between developed and backward regions, "many scholars believe that the State Council should formulate a unified standard" For those who need compensation for abnormal reactions caused by vaccination of class II vaccine, the draft proposes that the compensation costs shall be borne by the relevant vaccine marketing license holders The State encourages the establishment of a mechanism to compensate the recipients of abnormal vaccination reactions through commercial insurance and other forms "In fact, the Centers for disease prevention and control in all provinces now require vaccine companies to take out insurance However, due to different regulations, the insurance companies are different As a result of this fragmentation, vaccine companies may have to pay more to insure " Zhang Yi said Change 1: the highest penalty for making and selling fake goods is 30 times of the fine After the "draft for comments" was published in November last year, there was a high demand for the society to further improve the cost of illegal crimes During the deliberation of the draft vaccine management law, several members also thought that the punishment was not enough, and suggested to add codes to punish relevant illegal acts From the content of the draft, this call has been answered Previously, the draft for comments proposed that the vaccine marketing license holders who violate the provisions of the drug administration law shall be given a heavier punishment in accordance with the relevant provisions On the basis of the provisions of the drug administration law, the draft will further increase the penalties for serious violations, and raise the lower limit of the fine for illegal activities such as the production and sale of fake and inferior vaccines According to the current drug administration law, if the drugs produced and sold are fake drugs, the drugs illegally produced and sold and the illegal income shall be confiscated, and a fine of two to five times of the value of the drugs illegally produced and sold shall be imposed; if the drugs are inferior drugs, a fine of one to three times of the value of the drugs illegally produced and sold shall be imposed
On this basis, the draft raised the lower limit of the fine amount and clearly stipulated that if the vaccines produced and sold are fake drugs, the drugs and illegal income illegally produced and sold shall be confiscated, and a fine of more than five times but less than ten times the value of the goods shall be imposed If the value of the goods is less than 50000 yuan, a fine of 250000 yuan to 500000 yuan shall be imposed; if the circumstances are serious, the drug production license shall be revoked, and A fine of not less than 15 times but not more than 30 times the value of the goods shall be imposed If the value of the goods is less than 50000 yuan, a fine of not less than 1 million yuan but not more than 5 million yuan shall be imposed
If the vaccines produced and sold are inferior drugs, the lower limit of fine shall be increased from "one time to three times" to "two times to five times" If the value of goods is less than 50000 yuan, a fine of 100000 yuan to 300000 yuan shall be imposed If the circumstances are serious, a fine of 10 times to 15 times the value of illegally produced and sold vaccines shall be imposed If the value of goods is less than 50000 yuan, a fine of 5 times shall be imposed A fine of not less than RMB 0 million and not more than RMB 2 million Change 2: delete the restrictive provisions for infants and young children The reporter noted that the draft deleted the provisions that infants and young children are not allowed to be subjects of clinical trials of vaccines in the draft for comments Previously, the draft for comments proposed that "infants and young children should not be used as subjects in vaccine clinical trials If infants and young children really need to be used as subjects in the development of infant vaccine, the subjects should be selected from adults, carefully selected, and the subjects and age groups should be set reasonably." In the draft, the expression of this part is changed to "when conducting vaccine clinical trials, the subjects should be carefully selected and the subjects and age groups should be reasonably set up." The difference between vaccines and therapeutic drugs is that they are for health The safety of vaccines for human use has been preliminarily determined in the preclinical animal test stage In the clinical test stage, the general test sequence is from adults to children and then to infants, and only when the safety is basically confirmed can they be tested in infants "There are still some vaccines that cannot be vaccinated for adults and can only be used by infants and young children For example, BCG has a relatively strict age limit " He said According to Tao Lina, a vaccine science expert, vaccines are not therapeutic drugs The dose-response relationship is not linear There is no difference in the tolerance of vaccines between the older and the younger, so it is not necessary to test them on adults first At the same time, the provisions of the draft on the ethical review of vaccine clinical trials are further refined "The draft for comments" previously proposed that "to carry out the clinical trial of vaccine, it should be examined and approved by the ethics committee, and examined and approved by the drug regulatory department under the State Council." "The ethics committee shall review the scientificity and ethics of clinical trials, supervise the standardized development of clinical trials, and protect the legitimate rights and interests of the subjects." Zhang Yi believes that, in fact, this has been clearly stipulated in the current laws and regulations This time, it is incorporated into the draft, which can give more full protection to the rights and interests of the subjects Change 3: the draft Award for reporting the illegal behaviors of enterprises has been adjusted in many ways Tao Lina once proposed to establish a reward system for whistleblowers in enterprises, which is reflected in the draft Article 67 of the draft is intended to provide that rewards shall be given to those who report illegal acts of vaccines, and heavy rewards shall be given to those who report serious illegal and criminal acts of their enterprises or units Import and export vaccines will also be "different inside and outside" The person in charge of the vaccine manufacturer told the reporter that the draft was only for domestic vaccines and did not mention export vaccines However, there are different requirements for vaccines at home and abroad Therefore, the enterprise has proposed to increase export related content to avoid unnecessary restrictions on export vaccines In response, Article 64 of the draft clearly states that the exported vaccine should meet the standards of the importing country (region) and the requirements of the contract Legislative timeline: July 2018: according to the investigation organized by the State Food and drug administration, Changchun Changsheng found that in the production process of freeze-dried human rabies vaccine, there were serious violations of the drug production quality management specifications, such as record fraud ● October: the State Food and Drug Administration and Jilin food and drug administration respectively imposed a number of administrative penalties on Changchun Changsheng company ● on November 11, the half month consultation on the vaccine management law (Draft for comments) was started ● on November 25, the consultation on the vaccine management law (Draft) ended ● late November: the vaccine management law (Draft for review) was submitted to the State Council December 23: the seventh meeting of the Standing Committee of the 13th National People's Congress, the vaccine management law (Draft) was submitted for deliberation for the first time January 4, 2019: public consultation on vaccine management law (Draft) ● February 3: the public consultation ended.