Medical network - on February 8, 2 kinds of vaccines for "help" policy.
On February 7, issued by the general office of the state council general office of the state council on further strengthening the circulation of vaccines and immunization management opinions "(hereinafter referred to as" opinions "), clearly put forward "vaccine production enterprises can take 'main transportation warehousing + + area regional distribution relay mode distribution in different sections of the vaccine, trunk line transportation can entrust professional cold chain transport enterprises, regional warehousing and distribution can be entrusted with cold-chain distribution enterprise storage and transportation conditions. The provinces (autonomous regions and municipalities) people's government should combine actual research in our region to take effective measures, to ensure that remote area vaccine delivery in time".
At the same time, including "the organization carries out the second type of vaccine evaluation, selection, puts forward the second type of vaccine use item" and "trace information system construction, accelerate the vaccine take informatization means, strengthen the vaccine production, circulation and use process traceability management", "support the new vaccine especially multigang polyvalent vaccine research and development and industrialization" and "building a vaccine into or out of national immunization programmes", "step by step driving will be safe, effective and affordable by finance of the second type of vaccine into national immunization programmes" and other important revolutionary content have been released.
In almost 2 kinds of vaccine market after nearly a year after "freeze", "opinion" began to unlock the billions market 2 kinds of seedlings.
▍ vaccine "votes"
"In 2016 started vaccine" one vote ", this policy is for before the patch." Yesterday, there are long observation vaccine market of the personage inside course of study to the blue parker said.
Public data show that in 2016, nearly 570 million yuan of illegal operations in shandong vaccine Revelations, a sensation at home and abroad, also caused the who's high attention.
April, "the state council on amending the regulations on the administration of circulation of vaccines and vaccination decision", its core can't modify the content for 2 kinds of vaccine wholesale enterprise management vaccine, demanded units do "ticket, accounts, goods," consistent; Strengthen the whole of the vaccine cold chain storage and transportation management system, and establish the whole tracing system; Increase the penalties for illegal behavior and accountability efforts.
This is referred to as the vaccine industry then the impact of the policy of "one vote" is far beyond the initial expectations.
Around the public information shows that the New Deal announcement, 2 kinds of vaccine shortages, including some much-needed life-saving vaccine. Spring such as "southern weekly" reported that the national children with hand, foot and mouth disease was significantly increased trend, in the form of grim, but parents suffered no vaccine to play.
And the Beijing youth daily survey showed that the vaccine distribution adjustment is lagging Yu Xinzheng hopes.
First of all, the most basic of 2 kinds of vaccine sales channel is "closed", because many provinces have not yet set up vaccine procurement platform for bidding, and only the platform to build it an adjustment window period is long, shandong, anhui and other provinces, according to established vaccine bidding procurement platform, at least until the end of the year.
Second, new requirements, the vaccine production enterprise can only be 2 kinds of vaccine sales to county CDC, but small districts and counties centers for disease control and prevention of cold storage capacity, much more distribution centers for disease control and prevention can't save, enterprise distribution process is much less to run a few trips, increased operating costs. In addition, the vaccine production enterprise is directly responsible for distribution requirements, compared with the past, greatly extended the vaccine delivery time, but also have no incentive to enterprise for distribution to sparsely populated areas.
"Because in shandong vaccine and 2 kinds of vaccine of executing a vote, lead to a surplus of vaccine manufacturers, the upstream and many national large-scale outages county area without the worst effects of the vaccine available." The source said.
To this, the essence securities research report also drew the same conclusion.
The research reported that, in the near future look: vaccine wholesale enterprise, interests chain face reconstruction, the profit will be occupied by the primary circulation channel downstream shunt upward; Demand and the promotion of the 2 kinds of vaccines, supply channel is not smooth; Most vaccines enterprise distribution coverage narrowed, performance hit.
Medium term: 2 kinds of vaccine industry will have larger adjustment, cautious to industry growth; Vaccine circulation increase step by step a cancel + punishment, accountability efforts, the centers for disease control and prevention may result from a significant reduction in the purchase and the enthusiasm of vaccination; "Traceability system" and "tickets, books, cargo," labor requirements will lead to the consistency of the industry, regulation, the production, distribution, and inoculation level will be under pressure.
The long: cold chain management standardization; Will the industry reshuffle, to the management standard of enterprises; The public consciousness of immune enhancement, is expected to promote the second class of seedlings inoculated; The vaccine industry will continue to develop, but growth will be relatively slow.
▍ patch "votes"
According to China's pharmaceutical industry information center released "Chinese health industry blue book (2016 version)" pointed out that in 2015 China's biological drugs on the market sales of 109.5 billion yuan, accounting for about 8.2% of the total domestic medical market, vaccine products accounted for nearly one 5 of the size of the market nearly hundred million.
At present, China has the world's most vaccine production enterprises (about 36) as well as the biggest vaccine usage, quantity of nearly 1 billion times.
Due to historical reasons, the domestic market of 2 kinds of vaccine started relatively late, but because of the economic level and population based pull factors, 2 kinds of vaccine market to maintain 20% growth in recent years, both the market demand and growth space is very considerable.
2016-2021 Chinese children vaccine industry market supply and demand outlook depth study revealed that the vaccine industry in our country as a whole grew rapidly, the overall size increased from 2010, 9 billion yuan in 2014 to 20 billion yuan. Including 2 kinds of vaccine is a major role, the market occupies 59% of the total amount of vaccine market, scale of nearly 12 billion; A vaccine annual sales accounted for about 41%.
"" opinions" put forward by the vaccine production enterprise can adopt 'main transportation warehousing + + area regional distribution relay mode distribution in different sections of the vaccine, trunk line transportation can entrust professional cold chain transport enterprises, regional warehousing and distribution can be entrusted with cold-chain distribution enterprise storage and transportation conditions. The provinces (autonomous regions and municipalities) people's government should combine actual research in our region to take effective measures to ensure timely vaccine distribution in remote areas, 2016 policy for the "patch" and perfect, but also to the public of the medicine meet the actual demand and normal development." Yesterday, the expert inside course of study to the blue parker says about the topic.
The expert thinks, shandong vaccine decision, announced in April 2016 the state council on amending the circulation of vaccines and immunization management regulations > decision to cancel the qualification of pharmaceutical wholesale enterprises class-two vaccine, the vaccine production enterprise shall directly to the distribution of institution of disease prevention and control at the county level the second type of vaccine, the cold chain storage, transportation or entrust the industry distribution, commissioned distribution enterprise shall entrust the second vaccine distribution, the essence of vaccine to one vote per policy during the period of transition, exposed the phenomenon of shortage of vaccine, vaccination at the grass-roots level structure means that policy needs to improve in time.
Nowadays, remedial policies, joint also introduced the series of policies, though too late, but at least to rescue the market, the public and common dilemma faced by the enterprise; And the next step, the vaccine to layout of the market, the enterprise will be how to adapt to the new change is still a topic worth attention in the long-term.
The attached:
General office of the state council on further strengthening the circulation of vaccines and immunization management work
Countries do hair [2017] no. 5
The provinces, autonomous regions and municipalities directly under the central government, ministries under the state council, directly affiliated institutions:
Vaccination is the most economic, prevention and control of infectious diseases, the most effective measures to protect people's life safety and body health is of great significance. In order to further strengthen the management of circulation of vaccines and vaccination, in order to ensure the quality of vaccine and vaccination safety, agreed to by the state council, now put forward the following opinions:
A, improve the vaccine management mechanism
(a) a sound national immunization programmes vaccine adjustment mechanism. The national health and family planning commission to build a national immunization planning expert advisory committee; Organization according to the need of prevention work of institution of disease prevention and control to develop a vaccine against disease monitoring, comprehensive evaluation related disease burden and vaccine safety, effectiveness, health economics evaluation, production factors such as supply ability, after approved by the expert advisory committee argument, jointly with the ministry of finance proposed Suggestions about vaccine into or out of national immunization programmes, published after the approval of the state council. Step by step driving will be safe, effective and affordable by finance of the second type of vaccine into national immunization programmes, make people enjoy more high-quality service.
(2) improve the vaccination abnormal response compensation mechanism. Regions should strengthen inoculation against suspected abnormal reaction monitoring and reporting work, improve the level of immunization abnormal reaction survey diagnosis and appraisal. To encourage through commercial insurance and other forms of unusual vaccination response compensation mechanism, gradually establish a multi-level, including basic insurance, supplementary insurance, insurance compensation system, improve immunization abnormal response compensation efficiency. Before immunization abnormal response compensation insurance mechanism to establish, compensation work shall be in accordance with the existing provisions. National health and family planning commission jointly with relevant departments in abnormal summary vaccination response compensation insurance pilot work experience, on the basis of making perfect vaccination exception response compensation mechanism of guidance.
(3) establish circulation of vaccines and immunization management joint inter-ministerial meeting system. National health and family planning commission, food and drug supervision bureau jointly with the relevant departments to establish circulation of vaccines and immunization management joint inter-ministerial meeting system, strengthen policy coordination and cohesion, timely report work progress and information, joint research solve those outstanding problems that exist, collaborative response to major incidents, form the joint effort. The provinces, autonomous regions and municipalities according to the region's actual sound circulation of vaccines and immunization management coordination mechanism.
Second, promote the vaccine independent research and development and quality improvement
Support new vaccines, especially multigang polyvalent vaccine research and development and industrialization, strengthening the construction of industrial technology innovation strategy alliance and so on mechanism, through the national science and technology plan (special, funds, etc.), science and technology major projects such as scientific research project support eligible vaccine research and development work. Adhere to the national immunization programmes, conventional vaccines and vaccine emergency vaccination priority vaccine based on the principle of domestic production, such as large-scale production, encourage and support the domestic vaccine production enterprise with emphasis on key vaccine production capacity reserve to be able to meet the needs of the major public health event to deal with. Improve vaccine production enterprise quality management level and standardize the production capacity, continuing to improve the quality of vaccine products.
Third, strengthen the circulation of vaccines whole process management
(a) standard vaccines centralized purchasing work. Regions to the vaccine as soon as possible into the provincial public resources trading platform, according to the open and transparent, competitive, and the principle of fair trade for centralized purchasing online. Institution of disease prevention and control at the provincial level to collect the second type of vaccine demand in our region, in the provincial public resources trading platform through direct hang net, bidding or negotiations negotiation methods such as forming reasonable purchase price, institution of disease prevention and control to the vaccine production enterprise at the county level shall purchase supplies to the region after the vaccination units. Quality supervision, inspection and quarantine to strengthen the management of entry and exit vaccination work, completes the entry-exit personnel required for vaccine procurement, storage, use and so on each work.
(2) strengthen the vaccine cold chain distribution management. National health and family planning commission, food and drug supervision administration shall, in accordance with the regulations on the administration of the circulation of vaccines and vaccination, timely revision on vaccine storage and transportation management regulations, guidance to establish and perfect the vaccine cold chain distribution management system, strengthen the standardization of the storage and transportation of cold chain management.
Family planning, food and drug supervision department at the provincial level health to better guide the vaccine production enterprises to choose does cold chain storage and transportation conditions of distribution enterprises, giving full play to the advantages of centralized distribution efficiency. Vaccine production enterprises can adopt "trunk line transportation warehousing + + area regional distribution" relay mode distribution in different sections of the vaccine, trunk line transportation can entrust professional cold chain transport enterprises, regional warehousing and distribution can be entrusted with cold-chain distribution enterprise storage and transportation conditions. The provinces (autonomous regions and municipalities) people's government should combine actual research in our region to take effective measures, to ensure that remote area vaccine delivery in time.
(3) strengthen vaccine full traceability management. The food and drug supervision administration and national health and family planning commission shall accelerate the vaccine trace information system construction, take the information means, strengthen the vaccine production, circulation and use process traceability management. National health and family planning commission depends on the national health security information engineering, we will speed up the establishment of a national immunization information management system, gradually achieve different areas vaccination information exchange and sharing.
(4) strengthen the construction of the supervisory ability of the vaccine. Each region to strengthen the food and drug supervision department inspection, the inspection work force, promote to build professional, specialized drug inspector team, strengthen standardization training, improve the level of inspection specialization. Gradually improve the provincial drug inspection agency inspection ability of the vaccine.
Fourth, standardize management of the vaccination
(a) strengthen the management of the second type of vaccination as a whole. Of institution of disease prevention and control at the provincial level according to the region's disease surveillance information and disease prevention and control needs, the organization carries out the second type of vaccine evaluation, selection, puts forward the second type of vaccine use item, etc. At the county level according to the service population and family planning administrative department of public health service scope etc., determine the vaccination units within their respective jurisdictions, and publish to the society. In principle, the rural area in the villages and towns centralized inoculation mode. To strengthen communities, villages and towns vaccination outpatient service standardization, informationization, strictly regulate the village vaccination unit service behavior, may not be in violation of vaccination. For remote and inaccessible areas, through strengthening the towns and townships mobile services, improve the accessibility of vaccination, ensure the quality of vaccination.
(2) strengthen the vaccination units standardization construction. All regions to combining the reality of the region, in accordance with the law to promote vaccination unit standardization construction, regulate inoculation against unit set, personnel qualifications, the facilities condition, cold chain management, suspected inoculation against abnormal reaction monitoring treatment and inform, record, report and propaganda work, etc. Vaccination units shall, in the place significant position of the public to use vaccine varieties, taboo, inoculation methods, general and abnormal reaction, as well as the price of the second type of vaccines and vaccination service fee standards.
(3) strengthen the ability construction of vaccination. Strengthen public health physician training, and improve the professional technology level. Strengthening public hospitals, township hospitals and community health service center of preventive care departments (the department of public health) construction, enrich the technical force, the implementation of vaccination and other public health responsibility. Medical and health institutions to undertake vaccination responsibilities and tasks of medical personnel to pass at the county level health administrative departments of family planning vaccination professional training and examination of qualified of the organization.
(4) to strengthen technical guidance and assessment evaluation. The family planning administrative department of public health should strengthen vaccination work assessment, and the results of the appraisal shall be taken as basic public health service project subsidy funds transfer of important basis. The institution of disease prevention and control should strengthen the grassroots health institutions vaccination work of technical guidance, organize the region vaccination staff training.
Five, the implementation of security measures
(a) security personnel of institution of disease prevention and control. All localities and departments to earnestly implement about the relevant provisions of the centers for disease control and prevention institutions establishment standard, within the scope of the preparation of total, the implementation of the personnel of institution of disease prevention and control at all levels. Open recruitment, training and other measures to improve the overall quality of the contingent of disease prevention and control.
(2) to establish a stable mechanism of institution of disease prevention and control. The local people's governments at various levels to implement the responsibilities for spending, according to business development needs and development of disease prevention and control planning, full arrangement of institution of disease prevention and control of basic construction, equipment purchase, especially in cold chain system and information construction development and construction spending. Comprehensively considered the second type of vaccine management mode change and other factors, scientific and reasonable verification of institution of disease prevention and control of business of personnel expenditure, public funds and funds, full specified amount listed in the budget, by fiscal guaranteed, at the same level of service income according to the balance of two lines into the budget management.
(3) improve the performance salary system of institution of disease prevention and control. According to the high professional risk features of institution of disease prevention and control, scientific verification of institution of disease prevention and control of total performance salary. To establish a scientific and reasonable performance appraisal system, the formation and responsibility, work performance, the actual contribution associated assessment allocation mechanism. In accordance with the relevant provisions of the state, implement all allowance subsidy policies of disease prevention and control personnel.
(4) improve immunization related price policies. The provinces, autonomous regions and municipalities directly under the competent department of price to the second units immunization vaccination scientifically service fee standard. Each region to the relevant provisions of the implementation of this province (autonomous regions and municipalities) as soon as possible, completes the disease prevention and control institutions at the county level to the unit charge the second type of vaccine storage transport related work.
(5) to strengthen the propaganda guidance. Should fully give play to the role of traditional media and new media platforms, strengthen the circulation of vaccines and immunization knowledge popularization propaganda, highlight the importance of vaccination, safety, efficacy, and guide the masses to participate in the vaccination work, improve the vaccination rates. Perfect vaccination information release mechanism, strengthening public opinion surveillance, actively response to social and public concern, create a good social atmosphere.
Sixth, strengthen the supervision and inspection
People's government of provinces, autonomous regions and municipalities to combined the actual work, formulate specific implementation measures to carry out the apanage management responsibility, strengthen organizational leadership, such as vaccination work of disease prevention and control situation, the institution of disease prevention and control of fiscal policy implementation into government inspection content, such as strengthen the supervision and inspection, in accordance with the orderly circulation of vaccines and vaccination. National health and family planning commission, food and drug supervision administration jointly with relevant departments to strengthen supervision and inspection, timely to carry out the specific inspection, important situation report of the state council in a timely manner.
The state council general office
On January 15, 2017
(the public) |
