问题疫苗事件 谁为孩子唱挽歌

Vaccination is the only way for every baby's growth and development. Recently, an article "hundreds of millions of yuan of vaccine has not been refrigerated into experts in 18 provinces: This is murder" brought back the "570 million illegal vaccine case" in Jinan, which was cracked by the police in April last year and disclosed in early February this year, once again became the focus of public opinion and triggered social panic about vaccination.

Some people questioned that this incident was premeditated speculation, because it did not happen recently, but a year ago. At that time, Shandong police issued an investigation assistance notice to local drug regulatory departments, and all localities have organized recovery or seizure according to the vaccine batch number involved. Recycling started last year, and basically everything that can be recycled has been recycled! Other accounts have no records and cannot be recovered. It is estimated that they have expired! See here, Xiaobian's heart is only "ha ha"!

Some people treat this incident with the lucky attitude that the vaccine this time is an invalid vaccine rather than a fake vaccine or toxic vaccine.

Some people are angry, afraid and broken.

For those involved, we can curse, use Article 225 of the criminal law to stipulate the crime of illegal business operation, and even punish the crime of endangering public security by dangerous methods! But what we are really worried about is where the 570 million illegal vaccines are? Why do such problems occur again and again?

Of course, according to the current announcement, the vaccine involved in this case is invalid and may not be toxic. We don't have to be too alarmed. But parents simply can't imagine what kind of disaster it would be if their children had hidden dangers in vaccinating last year or this year.

Whether this happened last year or the year before last, whether there is a problem with the title "war of vaccine", and whether this vaccine is harmful. Lasting for 5 years, involving 25 kinds of human vaccines, flowing to 18 provinces and cities, involving an amount of about 570 million yuan... A case of illegal operation of human vaccines uncovered by Jinan police has an eye popping scope and time span.

At present, more than 16 million new newborns are born in China every year, and more than 1 billion doses of vaccine are injected every year. Now most areas require that you can't go to school without vaccination! 570 million invalid vaccines flowed out, what a terrible consequence! According to news reports, the problem vaccine is mainly in the circulation link, so that lawless people can take advantage of it. Is our country lack of legislation in this regard?

At present, vaccine circulation is not impossible.

China's relevant laws and regulations on human vaccines include: (1) law on the prevention and control of infectious diseases( 2) Drug administration law and normative documents related to vaccines, such as regulations on the administration of biological products, management measures for the production and supply of preventive biological products, management measures for the national planned immunization cold chain system, etc( 3) The regulations on the administration of vaccine circulation and vaccination and its supporting rules, conditionally liberalize the right to operate vaccines, and implement closed operation of class I vaccines; Liberalize the operation channels of class II vaccine( 4) Measures for identification of abnormal reactions to vaccination.

The regulations on the administration of vaccine circulation and vaccination, which came into force in 2005, clearly requires that the relevant conditions such as refrigeration, transportation and storage shall be met for engaging in vaccine business activities. Vaccine production enterprises and vaccine wholesale enterprises shall establish true and complete purchase and sales records in accordance with the drug administration law and the provisions of the drug regulatory department under the State Council.

In 2011, the seven departments issued the construction plan of vaccine supply system, pointing out that "vaccine management needs to be strengthened. Vaccine supply management involves multiple departments and lacks overall coordination at present. Vaccine circulation management is relatively weak ", and pointed out:" establish and improve the vaccine cold chain distribution management system, strengthen the standardized management of cold chain transportation process, and improve the quality assurance level of vaccine transportation ".

China does not lack legal constraints in vaccine management, so what is the problem?

As we all know, China's vaccines are divided into class I (free) and class II (self funded). Class I vaccines are purchased by the government through public bidding. Now they are basically open and transparent, and there is unlikely to be black box operation.

The second type of vaccine is different. It is directly provided by vaccine operating enterprises with relevant qualifications to disease control institutions or vaccination units. It belongs to self funded vaccination, with huge profit space and gray interest chain.

In this case, the vaccine business enterprise with relevant qualifications illegally sold the vaccine to unqualified personnel, resulting in the flow of class II vaccine into disease control departments and vaccination units after it was separated from the regulatory "extracorporeal circulation" for a period of time.

At present, the problem mainly lies in class II vaccines, which more or less reflects the loopholes in supervision. Where should the supervision of class II vaccines go now?

First, we should strive to incorporate some class II vaccines into class I vaccines.

Second, it is still necessary to reduce the circulation links in the middle of the vaccine. Since you take the road of marketization, you must allow price differences in order to mobilize the enthusiasm of market circulation. The national unified price can not be changed, so the market will have no enthusiasm for circulation. From this perspective, the vaccine is a product, you should allow it to circulate in the market, but, The state should strengthen the supervision and training of these personnel. For example, Pang, who was exposed in the Shandong vaccine case, can still do business during her probation. How can a criminal do business? This is clearly a regulatory error.

Third, relevant national departments or authorities, CDC and other health departments as well as local regulatory authorities should conduct regular spot checks on these vaccines. You should strengthen legal supervision, but there is a disease burden involved, that is, can class II vaccines be gradually included in class I vaccines? This involves national investment. We should consider our country's ability to bear the disease burden, and strengthen supervision in this process.

Since our supervision is not enough and the system is not perfect, can we see what suck lessons we can learn from abroad in vaccine management?

Germany: vaccine storage and transportation is like transporting biological and chemical weapons

After the vaccine is produced, it enters the link of storage and transportation. In order to ensure the safety of the vaccine, Germany used equipment similar to the transportation of "biological and chemical weapons" - vaccine cold chain.

Vaccine cold chain refers to the storage, transportation and refrigeration facilities and equipment equipped to ensure the quality of vaccines during operation from the production enterprise to the vaccination unit. In addition to the driver's cab, all special vaccine transport vehicles in Germany are made of special materials with good light protection and sealing performance. Each vehicle has the functions of heat, static electricity and radiation protection. At the same time, each vehicle is also equipped with two armed security personnel, whose security level can be compared with military vehicles transporting "biological, chemical and nuclear weapons". After the transporter transports the vaccine to the vaccine companies in each state, it will be put into a special vaccine warehouse. The variable temperature storage cabinet in the warehouse can adjust the corresponding temperature according to the different needs of each vaccine.

UK: strictly control the qualification of vaccine manufacturers. There are only 7 manufacturers in the UK

The approval and production of vaccines are the first and crucial link in the vaccine safety chain. The British government attaches great importance to this.

The UK strictly controls the qualification of vaccine manufacturers. There are 64 registered members of the British Pharmaceutical Industry Association, of which only 7 have obtained the vaccine manufacturer qualification of the British Ministry of health. There are two reasons for the small number: first, the British Ministry of health has a special vaccine qualification examination and management organization. To obtain production qualification, we must pass strict assessment, such as research and development capacity, production equipment, capital, etc. Second, the UK provides free medical services for all. The UK Ministry of health is the largest vaccine purchaser in Europe, with an annual fund of more than £ 200 million for vaccine procurement. All vaccines required by the British people are uniformly purchased by the UK Ministry of health. As the British Ministry of health is the only buyer, its monopoly purchasing power gives it a great say in the negotiations with vaccine manufacturers, and its contract price is far lower than the market price announced by the manufacturer. Therefore, there are more and more vaccine varieties on the market in the UK, but the number of vaccine manufacturers is getting smaller and smaller. The strong pricing power of the British Ministry of health has thinned the profits of vaccine production, making many enterprises withdraw from this field.

The UK's drug and health products regulatory agency and the health agency are responsible for monitoring the safety of vaccines. The UK requires that each batch of biological products, including vaccines, must be tested for quality and effectiveness before they are put on the market. Only through this test can they be approved to enter the market. The test is divided into two levels, first by the manufacturer, and then by one of several official drug testing laboratories recognized by the EU.

Britain attaches great importance to the stability of vaccine supply. Britain tries to avoid the situation that a vaccine can only be produced by one enterprise, because over reliance on one enterprise will affect the stability of supply. In Britain, the only manufacturer shut down due to pollution, resulting in supply interruption.

Japan: adverse reaction monitoring: all accidents are reported

In 1996, there was a famous "hepatitis B vaccine" incident in Japan. In those days, the hepatitis B vaccine produced in Japan used the serum of AIDS and hepatitis patients as raw materials, leading to partial vaccination. After the incident, the Japanese Ministry of health and welfare and manufacturers did not inform the public, but united to try to cover up the truth, resulting in more vaccinators becoming innocent victims. Learning from the bitter experience, the Japanese government began to strictly manage this.

First, add third-party doctors and experts to the existing adverse reaction monitoring institutions. That is, in addition to the Ministry of health and welfare and vaccine R & D institutions, the participation of doctors and experts not designated by the Ministry of health and welfare shall be increased. Strengthen social supervision and put an end to corruption.

Second, manufacturers should report all adverse reactions of their vaccines - "zero" report, rather than the so-called "safety ratio", that is, the system that adverse reactions are not reported under a certain ratio.

Therefore, this time, with an attitude of reverence for life, we will really severely punish once. Can we seriously improve the management and supervision system through this matter? Let next year, the year after next, the year after next... Your, my and every family's children can be vaccinated safely and safely, so that such incidents will never happen again and such evil acts will never happen again. okay?