The outstanding feature of this regulation is to clarify the government's responsibility, fix the government's responsibility for vaccination in the form of regulations, and standardize the behavior of vaccine production and operation enterprises, disease prevention and control institutions and vaccination units, with the ultimate goal of protecting the rights and interests of vaccinated people from damage.
First, there is no longer any charge for vaccination of the first type of vaccine.
The Regulations divide all vaccines into two categories, namely, Class I vaccines and Class II vaccines. The difference is that a vaccine is free and paid by the government; The second kind of vaccine is voluntary and the cost is self-care. At present, there are five kinds of vaccines determined by the national immunization program, namely hepatitis B vaccine, BCG vaccine, measles vaccine, polio vaccine and DTP vaccine. Some provinces have increased JE and meningococcal vaccines. In the past, in addition to the vaccine itself, vaccination units also charged vaccination service fees and vaccination consumables fees, generally between 2 yuan and 4 yuan. After the implementation of the "Regulations", the vaccination unit shall not charge any fees to the vaccinated person when vaccinating the first class vaccine, including vaccination service fees and vaccination consumables fees. The whole process from vaccine distribution to vaccination, that is, from disease prevention and control institutions to vaccination units to vaccination population, must be paid by the government.
Second, the financial department of the government will provide financial guarantee.
The premise of realizing the free vaccination of the first class vaccine is that the financial departments of governments at all levels should give sufficient financial guarantee. The regulations clearly stipulate that governments at all levels should incorporate immunization programs into national economic and social development plans. On the one hand, they should ensure the funds, on the other hand, they should ensure the vaccination rate and the implementation of the national immunization plan. Governments at all levels have also made specific provisions on how to obtain free vaccination. The people's governments at the provincial level shall ensure the funds needed for the procurement of Class I vaccines and the funds for the construction and operation of the cold chain system. The people's government at the county level is responsible for the expenses incurred by free vaccination, including subsidies for vaccination personnel.
Third, someone is responsible for the abnormal reaction damage.
What is no fault? In other words, there is no problem with the quality of the vaccine itself, the vaccinators have not violated the rules, and the vaccinated people have not concealed their health status and vaccination contraindications. In view of the fact that the abnormal reaction has caused actual damage to the health of the vaccinator, in order to effectively protect the rights and interests of the vaccinator and eliminate the ideological concerns of the vaccinator and the vaccinator, the Regulations stipulate that the vaccinator shall be given a one-time economic compensation for the death, disability or organ and tissue damage caused by the abnormal reaction. Among them, the government should bear the compensation for the abnormal reaction caused by the first-class vaccine, and the manufacturers should compensate for the abnormal reaction caused by the second-class vaccine. Specific compensation standards shall be formulated by the provincial government. The "Regulations" also lists six situations that are not abnormal reactions, and the damage caused by them should be handled in accordance with the principle of fault compensation and the provisions of relevant laws and regulations. If the vaccine quality is unqualified, it shall be handled in accordance with the relevant provisions of the Drug Administration Law. If the inoculation unit is at fault, it shall be handled in accordance with the relevant provisions of the Regulations on the Handling of Medical Accidents.
The "Regulations" stipulate that after an abnormal reaction occurs, the inoculation entity or the recipient may request the competent health department where the inoculation entity is located to handle it. In other words, the health department is not the only department dealing with abnormal reactions, and it can also be solved through consultation or litigation. The identification of abnormal reactions shall be carried out with reference to the Regulations on Handling Medical Accidents, and the specific measures shall be formulated by the Ministry of Health in conjunction with the State Food and Drug Administration of the United States.
Fourth, standardize the vaccination behavior of disease control institutions.
According to the regulations, the inoculation unit is designated by the county-level health authorities in medical and health institutions, which is mandatory. It is essentially different from other medical activities. Whether medical institutions like it or not, vaccination must be carried out once they are designated. If they are not designated, they can apply voluntarily. In the past, disease prevention and control institutions at all levels could naturally carry out vaccination work without designation or approval. This situation will change, because the regulations stipulate that vaccination units should have the practice license of medical institutions, so disease prevention and control institutions must obtain the practice license of medical institutions and set up vaccination clinics to carry out vaccination work; If vaccination is not carried out, we should also do a series of work related to vaccination, such as publicity, training, technical guidance and monitoring.
Disease prevention and control institutions cannot carry out mass vaccination work on their own, because the regulations clearly stipulate that no unit or individual may carry out mass vaccination work without authorization. In the past, disease prevention and control institutions could organize mass vaccination. In the future, only health authorities at all levels can organize mass vaccination according to the monitoring and early warning information of infectious diseases, and must report to the government at the same level for decision in advance and report to the health authorities at the next higher level for the record. In addition, after the implementation of the regulations, the phenomenon that the disease prevention and control institutions released the second-class vaccine information in the past will also change. For example, in the future, information suggesting that the public should be vaccinated against influenza during influenza epidemics can only be released by the Ministry of Health and the Provincial Health Department.
We need to use laws to protect our legitimate rights and interests, which is a problem that everyone should understand clearly. Please consult a professional lawyer if you have any other questions.