The country introduced a new policy of vaccine management： the public welfare of disease control departments was enhanced, and the profit-making space was compressed.

April 23, 2014, vaccine storage and transportation place-cold chain construction system-Beijing Sankangdele North District Operation Center. Vision china diagram

On April 13th, Li Keqiang, Premier of the State Council of the People’s Republic of China presided over the the State Council executive meeting, listened to the report on the investigation and handling of a series of cases of illegal operation of vaccines in Jinan, Shandong Province, decided to hold a group of responsible persons accountable first, and discussed and passed in principle the Decision of the State Council on Amending the Regulations on the Administration of Vaccine Circulation and Vaccination (Draft) (hereinafter referred to as the revised draft).

The Paper (www.thepaper.cn) noted that,The revised draft has greatly adjusted the circulation mode of the second type of vaccine, canceled the link of drug wholesale enterprises to operate vaccines, and handed over the second type of vaccine to the provincial disease control department for centralized procurement.

On the evening of April 13th, Mingde Yu, former director of the Finance and Circulation Department of the State Administration of Traditional Chinese Medicine, and now president of China Pharmaceutical Enterprise Management Association and China Pharmaceutical Entrepreneurs Association, told The Paper that canceling the vaccine wholesale business would shorten the circulation chain and reduce the number of monitored objects, which would help to enhance the monitoring effect.

Song Hualin, a professor at Nankai University Law School who has long been concerned about vaccine supervision, said,On the one hand, the revised draft indicates that in the future, the sales price of the second-class vaccine will be more transparent from the factory to the final inoculation, and the space for the disease control department to increase the price and profit will become smaller; On the other hand, in the past, the disease control department had to make money by selling the second-class vaccines. This revised draft included the funds of the disease control department in full in the budget, which increased the public welfare attribute of the disease control department and curbed its profit-seeking motivation.

Reduce circulation links and reduce the difficulty of management and control.

On April 13th, the Legislative Affairs Office of the State Council released a message explaining the revision of the Regulations.

The news pointed out that in view of the long circulation chain and large profit-making space of the second-class vaccine exposed in the case, the draft deleted the provisions of the Regulations that pharmaceutical wholesale enterprises can operate vaccines after approval, and compared the voluntarily vaccinated second-class vaccines with the first-class vaccines used in the national immunization program, all of them were included in the provincial public resource trading platform for centralized procurement, and pharmaceutical wholesale enterprises were no longer allowed to operate vaccines.

In addition, in view of hidden illegal business practices such as "hanging tickets", the draft stipulates that disease prevention and control institutions and vaccination units should establish true and complete records of purchase, storage, distribution, supply and receipt in accordance with regulations, so that tickets, accounts, goods and payments are consistent.

"Ticketing" is a slang word in the vaccine industry, which means that an individual who can find a vaccine is affiliated with a pharmaceutical production or wholesale enterprise and sells vaccines (drugs) to medical institutions by himself. When necessary, the affiliated pharmaceutical production or wholesale enterprises shall provide business licenses, pharmaceutical business licenses, etc., implement public-to-public transfer transactions, and finally divide them into shares.

On the evening of the 13th, Mingde Yu, president of China Pharmaceutical Enterprise Management Association and China Pharmaceutical Entrepreneurs Association, told The Paper: "Pharmaceutical wholesale enterprises are no longer allowed to operate vaccines, the circulation chain of the second-class vaccines is obviously shortened, and the number of monitored objects is reduced, all of which are conducive to enhancing the monitoring effect." Mingde Yu said that the number of pharmaceutical wholesale companies operating vaccines is also very large, and it is very difficult to control them. The revised draft specifies that the second-class vaccines will be directly sent to the disease control department by the production enterprises according to the management of the first-class vaccines. This process is a planned management method, which is convenient for concentrating on strengthening control.

Song Hualin, a professor at Nankai University Law School, also believes that the elimination of drug wholesale enterprises from the vaccine circulation link will reduce the vaccine circulation process and play a certain role in solving the problems of "extracorporeal circulation" of the second-class vaccine.

"In the past, vaccine manufacturers could sell second-class vaccines to wholesale enterprises or directly to disease control departments; Wholesale enterprises can also sell vaccines to other wholesale enterprises or directly to the disease control department; The disease control department can also sell the second-class vaccine to the lower-level disease control departments and vaccination units. " Song Hualin said that the second-class vaccine illegally flowed into the hands of some people who actually had no vaccine business qualifications, which was partly caused by the cumbersome circulation of vaccines.

Increase the public welfare attributes of disease control departments and curb their profit-seeking motives.

"It’s not that the vaccine is removed from the circulation enterprises, and the vaccine will sit back and relax in the future, absolutely not." Mingde Yu said,Driven by interests, even if the circulation mode of vaccines is changed, it is also necessary to prevent some personnel in the disease control department from taking risks to buy and sell vaccines for personal gain. "So the system depends on supervision.No matter how good the system is, some people try to seek personal gain, but when the legal system is sound, there is less room for them to rent and less chance for them to succeed. "

However, during the revision of the Regulations, the National Health and Family Planning Commission also released information that it will ensure the implementation of the staffing of disease control institutions at all levels in accordance with the provisions of the Guiding Opinions of the Central Organizing Committee, the Ministry of Finance and the Health and Family Planning Commission on the Organization Standards for Disease Control and Prevention. The personnel funds, public funds and business funds of disease control institutions should be fully included in the budget, and the part with insufficient financial input should be carefully verified and guaranteed by the finance at the same level. Scientifically verify the total performance salary of disease control institutions and implement dynamic adjustment. Establish a scientific and reasonable performance appraisal and performance salary distribution system. Scientifically check and approve the storage and transportation fees of the second kind of vaccine in county-level disease control institutions and the standards of vaccination service fees for vaccination units.

Song Hualin also believes that reducing the circulation link does not mean that there is no risk, and how to control it will be faced in the future.

Song Hualin said that it is not difficult to see from the information released by the National Health and Family Planning Commission that the norms and constraints on the disease control departments were obviously insufficient in terms of legal provisions and implementation status. Institutions are divided into public welfare category I and public welfare category II. One category is completely public welfare, and all expenses are fully funded by the government, including undertaking compulsory services, compulsory education, basic scientific research, public health, etc. Disease control belongs to public welfare category I..

"On the one hand, vaccine manufacturers should be required to standardize quality management behaviors, and enterprises should ensure that the corresponding sales records are true and complete while self-checking; On the other hand, in order to increase the public welfare nature of the disease control department, in the past, the disease control department had to increase financial support, curb its profit-seeking motivation and standardize its operating procedures in order to make money by selling the second-class vaccine.. Song Hualin said that this is also the reason why the funds of the disease control department should be included in the budget in full in the revised draft, that is, to ensure the funds of the disease control institutions and not to make profits.

Song Hualin said that the approval of the storage and transportation fees of the second type of vaccine and the vaccination service fee standards of vaccination units indicates that the sales price of the second type of vaccine will be more transparent from the factory to the final vaccination.