Uncovering the grey interest chain of class II vaccine: illegal price increase at the vaccination station of purchasing, taking and kickback

Source: first financial daily March 24, 2016[“ For class II vaccines, the policies of each province are different, but most of them take the disease control system as the main transit station Enterprises will sell vaccines to the disease control department through agents, and then distribute them to the disease control system at all levels, and finally arrive at the vaccination point However, in the process of transmission, the prices of each layer are different For example, the vaccines purchased by the disease control department at the upper level at 20 yuan each will cost 60 yuan The price of RMB is sold to the next level, and the next level unit will sell it to the vaccinator at a price of RMB 100 However, the second kind of vaccine can be purchased from other institutions without using the disease control system As a result, there are vaccine sales companies, representatives, etc., and fleeing products will appear For the same vaccine, they only need 30 yuan a dose, and the vaccination point of course needs this vaccine with a larger markup space " ]Profit seeking has become the ultimate cause of safety incidents in many industries, as well as in the field of vaccines, and profit seeking behaviors that affect vaccine safety have been sustained in the dark Although the state has repeatedly requested to control the links involved in vaccine safety, from the batch issuance of production to the qualification certification of sales, as well as the electronic supervision code of the vaccine traceability system, and even the notification signature of the terminal vaccination point, the vaccine safety exposed to interests is still under threat Among them, the gap and regulatory vacuum in China's disease control system began to expose the risk of deposition and concealment The "business" of self funded vaccines in order to better maintain life and health, the state has issued the immunization plan, a kind of vaccine is fortunately unified bidding and distribution by the state, and after free vaccination, no one peeps into its interests But category II vaccine has become a commodity Besides the disease prevention mission it carries, it has been put on the market According to China's regulations on the supervision of biological products such as vaccines, vaccines can be divided into category I and category II vaccines, among which the vaccine varieties in the national immunization plan are as category I vaccines, all of which are reported to the vaccination plan by the vaccination unit and distributed by the state for free; for category II vaccines that need to be inoculated at their own expense, they can be directly distributed to the disease control institutions or vaccination units by the vaccine business enterprises with relevant qualifications To be provided As a high-risk special drug management vaccine, at present in China to implement a strict system of batch issuance Enterprises engaged in vaccine production and management must also have corresponding qualifications - vaccine production enterprises, wholesale enterprises, disease control departments at all levels and other vaccination units, which constitute the common ecology of vaccine industry within the policy barriers And free priced second-class vaccines have naturally become the biggest business in the industry The normal circulation mode of a class II vaccine is manufacturer → distributor → provincial disease control → Municipal Disease Control → County disease control → vaccination point In this process, the price is increased layer by layer, with huge space Even if the disease control system flows, the price will be increased Huge space is the foundation for vaccine dealers to make money Double the interest space several times, let the second class vaccine feed a lot of people "Before SARS, there was no government support for the basic level disease control system Most people relied on themselves to find food Many people found businesses and even sold coal ball stoves." One health system person said It is the long-term survival habit of self-reliance that leads to the emergence of selling low-cost short-term vaccines, and also creates greater profit space "For class II vaccines, the policies of each province are different, but most of them take the disease control system as the main transit station Enterprises will sell vaccines to the disease control department through agents, and then distribute them to the disease control system at all levels, and finally arrive at the vaccination point However, in the process of transmission, the prices of each layer are different For example, the vaccines purchased by the upper level of disease control department at 20 yuan each will cost 60 yuan The price of RMB is sold to the next level, and the next level unit will sell it to the vaccinator at a price of RMB 100 However, the second kind of vaccine can be purchased from other institutions without using the disease control system As a result, there are vaccine sales companies, representatives, etc., and fleeing products will appear For the same vaccine, they only need 30 yuan a dose, and the vaccination point of course needs this vaccine with a larger markup space " A person from the grass-roots food and Drug Administration said "Every enterprise has its own sales channels for class II vaccines Some enterprises have their own sales teams, some enterprises sell through the agent model, and then the general agent continues to grade However, most of the second class vaccines are sold to the disease control department, not to the vaccination points of medical institutions, because the distribution is more difficult After the class II vaccine enters the disease control department, it will be distributed by the disease control department However, as the second category vaccine belongs to voluntary vaccination, the quantity is difficult to control, and the vaccine is easy to appear near effective period vaccine Once such vaccine appears, in order to deal with the inventory, both dealers and disease control departments will have a big sale Many of these sold vaccines flow to personal agents, and then enter the vaccination point at a relatively low price " A person from a vaccine manufacturer said "For these vaccines in the near term, if the unqualified individual wants to buy them, the disease control department or the vaccine dealer will help him to get the qualification, find a qualified company, list and ship them No one knows where the vaccines in the near term go Because the vaccines in the near term are all processed at a low price, no one wants to damage them What's more, where there is a need for low-cost vaccines, it brings space for these individuals who are fleeing the goods " Said the local food and drug administration system personnel In November 2015, the Discipline Inspection Commission of Guangyuan City, Sichuan Province announced a recent case of corruption in the disease control system, in which the staff took kickbacks in the process of vaccine procurement and sales, and the grassroots vaccination stations increased their prices in violation of regulations According to the investigation, Liu Mou, former deputy director of Guangyuan CDC, explained that many cadres in the local city and county CDC system had the problem of accepting bribes, and even made money by actively increasing the price of vaccines, and the price increase part was used as an additional rebate In 2012, Sun Mou, then director of the CDC of Chaotian District, Guangyuan City, took the initiative to ask the supplier to increase the price of JE vaccine from 20 yuan / piece to 40 yuan / piece, of which 20 yuan was divided by the supplier and CDC cadres, from which Sun Mou got 96000 yuan The investigators found that since 2008, the total amount of vaccines purchased at the municipal and county levels in Guangyuan has reached more than 60 million yuan, and the share of suppliers Zhao alone has reached more than 20 million yuan According to Zhao, in order to ensure the market share, he formulated a set of specific and detailed "rebate standards" according to the vaccine varieties, procurement methods and the role of cadres, and reached an tacit agreement with relevant personnel According to different standards such as 10 yuan, 5 yuan and 1 yuan, he collected rebates for cadres of the disease control system, made one sales rebate, settled one immediately, and strictly followed them“ The hidden rules Other mountain's Stone: the vaccine management in the United States is gradually improved after the tragic vaccine safety incident Song Hualin, associate professor of Law School of Nankai University and senior researcher of changce think tank, previously wrote that in the process of vaccine regulation in the United States, the cutter laboratory event in 1955 was a milestone The polio vaccine prepared by cutter laboratory failed to kill all the viruses due to incomplete inactivation of the corresponding viruses with formalin 120000 children were vaccinated by cutter laboratory As a result, 40000 children were infected, 260 of them were paralyzed and 110 died This has led to stricter standards and controls on vaccines in the United States The National Institutes of health upgraded its biological product control laboratory to 7 laboratories under its jurisdiction, which is the biological standard department with independent entity status, and promoted the rise of vaccine adverse reaction monitoring system On July 1, 1972, the Department of biological standards was incorporated into the United States Food and Drug Administration (FDA) At present, FDA's Center for biological product review and Research (CBER) plays an important role in vaccine regulation Song Hualin pointed out that FDA A vaccine safety team composed of representatives from the office of biological statistics and epidemiology, the office of communication, training and manufacturer assistance, the office of law enforcement and quality of biological products, the office of director and other departments is formed to respond to vaccine safety issues quickly When the FDA considers that the marketed vaccine has immediate or substantial danger to public health, it can order vaccine manufacturers to recall or remove their vaccines from the market But China's current laws are not strict with the illegal operation of vaccines—— According to the provisions of the criminal law of the people's Republic of China, the drug administration law of the people's Republic of China and other laws and regulations, it is an illegal crime to sell vaccines without qualification for vaccine business, and may be sentenced to fixed-term imprisonment of not less than five years in accordance with the law; those who know others do not have qualification for legal business and still provide vaccines can be regarded as joint crimes and investigated for criminal responsibility in accordance with the law.