Formulate a priority R&D catalog for six departments to break the bottleneck of supply and demand of children's medicine

Source: on June 4, 2014, the official of the health and Family Planning Commission told the reporter of the daily economic news that the development of the priority R & D catalogue for children's drug use is in the beginning, and the decision-makers hope that it will be in 2014 In the second half of the year,

on the basis of the 13th five year plan, we put forward a preliminary list of children's drug priority research and development varieties for the reference of relevant departments in scientific research projects The contradiction between supply and demand forces the examination and approval to welcome "special channels", aiming at 2.2% of the total population of 16.6% One of the biggest problems is the lack of suitable drug specifications and drug usage The original intention of the six ministries and commissions to issue the opinions is to solve the "most important problem and the most prominent contradiction" According to the requirements of the six ministries and commissions, a "special channel" will be set up in the process of children's drug application and review, especially for children's suitable varieties, dosage forms and specifications that have been put on the market in foreign countries but are lacking in China and urgently needed in clinical practice,

so as to accelerate the progress of application and review In terms of R & D innovation mechanism, relevant departments will gradually establish a list of children's drugs to encourage R & D according to the needs of China's children's disease prevention and control, drawing on international experience, and incorporate it into the national major science and technology special project of "major new drug creation", major innovation and development projects of protein biological drugs and vaccines, integrate advantageous units to cooperate in R & D, improve the ability of independent innovation of the industry, and introduce Guide and encourage enterprises to give priority to R & D and production It is worth noting that the research and development of children's drug use in China has lagged behind for a long time, which forces the decision-makers to pay attention to and strengthen the control of clinical trials of children's drug use, and will make efforts to improve the participation of subjects At the same time, to explore the establishment of a new drug application system to provide relevant children's clinical trial data and drug information For the listed varieties,

drug manufacturers are required to timely supplement and improve the clinical trial data of children According to the reporter of "daily economic news", the opening of "special channel" is just the beginning "Next, whether through separate sorting or setting up special channels, there will be corresponding measures in the future." The above-mentioned health and Family Planning Commission officials said that after the introduction of the opinions, the operational means should follow the declaration items of different categories and different products to refine and take into account different review sequences, with only one purpose, that is, to speed up the review progress of relevant products In addition, according to the information held by the reporter,

for the frequent drug shortage in children, the opinion will promptly promote the implementation of the early warning mechanism, "don't wait for the lack of drugs to respond, you must timely feedback, and timely start the relevant supply guarantee work" Said the health and Family Planning Commission official In addition to the favorable policies in the application and approval process, the development of children's priority R & D Catalogue under the leadership of West China Hospital is also advancing in an orderly manner on the basis of the opinions In fact, NPC and CPPCC have commissioned the research institutes of West China Hospital to learn from foreign experience and experience incidence rate and incidence of diseases in children The research work led by Huaxi Hospital specifically involves the lack of appropriate dosage forms and dosage specifications for different disease types,

and then through full demonstration by academic experts, a rigorous consensus is formed, and then it rises to a directory to guide enterprises to focus on this aspect in national research projects, and also guide relevant research parties to focus on the key For diseases, especially common and frequently occurring diseases of children, targeted research and development of drugs should be carried out During the preparatory work of West China Hospital, relevant departments are also studying similar directories in some developed countries to encourage research and development of drug use for children, in order to guide enterprises and research departments to focus on investment and avoid disorder in research and development In addition to the launch of priority catalogue R & D, there will also be continuous policy improvement in drug price difference rules The so-called differential price comparison rule of drugs refers to the difference or ratio between the prices of drugs due to different dosage forms, specifications or packaging Specifically,

it includes three forms: dosage form differential price, specification differential price and packaging differential price According to the information mastered by the reporter, the next decision-making level will further study the appropriate dosage forms for children, such as the dosage forms that are convenient for children to use and take, and the differential valence coefficient may be relatively loose, but there is no specific study on what dosage forms are Moreover, in the aspect of drug instructions for children, after the introduction of the opinions, the policy improvement work of continuous follow-up will be carried out, that is, the reasonable revision of drug instructions Specifically, the listed drug companies have the responsibility to supplement the relevant data, so that their drug instructions can give a more clear range of drug use for children, including indications and dosage, so that clinicians can more clearly follow, and more scientific when prescribing and prescribing drugs With the continuous revision of children's drug specifications,

including the joint efforts of the State Food and drug administration, the health and Family Planning Commission and other ministries, he said, "we hope to see great progress in some drugs by enterprises this year, so as to make the specifications more clear." One issue worthy of attention is whether, with the "loose" adjustment of the above differential price coefficient, the corresponding drug price will be increased and the burden of patients will be increased under the situation of encouraging the production of enterprises? The reporter learned that in order to solve the above problems, relevant departments should explore the establishment of a price negotiation mechanism to promote the reduction of drug prices for some clinically necessary imported children drugs that are still under patent protection In the next step, we should give full play to the function of medical insurance to protect children's drug use, and timely include appropriate dosage forms and specifications into the insurance coverage according to the regulations These two points are expected to play a positive role in reducing the drug price of children in the next step A person from the price department of the national development and Reform Commission said that for a long time, price is an important means to regulate supply and demand It is necessary to encourage enterprises to produce, but not to increase the cost of the masses too fast On the one hand, government regulation and control is necessary On the other hand, it is necessary to play an active role in market competition In the implementation of the opinions, this rule is also followed So, how to effectively cover the benefits of health insurance for children's medicine in the future?

According to a person from the medical insurance Department of the Ministry of human resources and social security, after the coverage of medical insurance was extended to children and the unemployed elderly, the Ministry of human resources and social security made a temporary supplement at that time, adding 36 varieties limited to children In fact, as long as the drugs are within the scope of the catalog, they are within the scope of payment of the medical insurance fund In terms of varieties, if the drugs are crowned with "children", "children", "children's use", "children's use" and "children's use" in front of them, they are all included in the medical insurance catalogue That is to say, as long as the medicine itself is in the medical insurance catalog, if the prefixes of "children" and "infants" are added in front, the medical insurance will be reported The Ministry of human resources and social security is also making supplements to the dosage forms If there are oral granules in the catalogue, and if there are granules and oral liquids suitable for children,

including solutions, oral liquids and syrups, they will be included in the payment scope of the medical insurance fund As for the schedule of when the relevant children's medicine will be included in the medical insurance of the Ministry of human resources and social security in the future, the said person said, "it must be announced together with the adjustment of the catalogue If it is a newly developed new variety, new dosage form and new specification for children, the medicine will generally be in the catalogue." The new policy has brought benefits to promote the development of the industry China's children's drug market has broad prospects China's children's drug sales will continue to maintain an annual growth rate of more than two digits, and it is expected to reach 66.9 billion yuan by 2015 However, according to the statistics of white paper on Chinese children's drug use in 2013, as of January 2013,

there were more than 180000 domestic drug approvals in China, of which only more than 3000 are dedicated to children, involving more than 400 varieties For many manufacturers, the field of children's medicine is a barrier that they do not want to cross But in the near future, more enterprises will cross this barrier The state attaches great importance to children's drug use, and supports the industry through encouraging research and development, accelerating application and approval, strengthening quality supervision, promoting rational drug use and other policy links In such a favorable situation, enterprises will have greater enthusiasm to invest in R & D sources.