Drug developers can make dowry for themselves

Source: on March 23, 2017, www.renmin.com, pharmaceutical research and development institutions or researchers could not apply for registration of drugs, but could only sell the results to manufacturers at a low price, which will gradually become a history In June last year, the State Office issued the pilot program of drug listing license holder system, which stipulates that drug research and development institutions or scientific researchers can also obtain drug approval numbers, and those with corresponding qualifications can produce by themselves or entrust production enterprises to produce As a pilot province, Sichuan selects five regions with more developed drug R & D and production such as Wenjiang District of Chengdu as the pilot work demonstration area Recently, Sichuan food and Drug Administration formulated a series of implementation plans, which not only determined the rights and obligations of the holders and the entrusted production enterprises, but also made it clear that the provincial finance will give one-time rewards to the top 10 drug listing license holders who have obtained the drug approval number What is the effect of the pilot? Has the enthusiasm of researchers increased? The reporter conducted an investigation in Sichuan Registration and production are separated Research and development results are no longer cheap According to the previous regulations, China implements the mode of integration of marketing license and production license for domestic drugs Only drug manufacturers are allowed to obtain drug approval number and produce the drug Because drug R & D institutions and researchers cannot obtain drug approval number, they can only transfer relevant drug technology to drug manufacturers after obtaining new drug certificate "This model of cutting green shoots has affected the enthusiasm of drug research and development." Chen Jing, head of relevant departments in Wenjiang District, Chengdu, said that by "bundling" drug registration and production license, drug research and development institutions and researchers can only sell the achievements after great efforts to production enterprises, and often at a lower price Liu Changfeng, head of Shengkang pharmaceutical company in Wenjiang District, admitted that new drug research and development is a long time span, huge investment and uncontrollable risk "If it wasn't for local policy support, it might have been abandoned." Liu Changfeng said that before the implementation of the drug listing license holder system, there was not even a pharmaceutical factory willing to cooperate with him The reason is simple: for a new drug, its market reaction and actual efficacy are unknown, and almost no pharmaceutical enterprise dares to buy the technical rights of the new drug In this case, only a few powerful pharmaceutical companies can engage in new drug research and development for a long time "It's more about generics." Liu Changfeng told reporters that compared with new drugs, the market efficiency of generic drugs can be expected, and pharmaceutical companies are more willing to buy generic patents for production According to the provisions of the pilot project, drug research and development institutions or researchers can also obtain drug approval numbers, produce drugs by themselves, or entrust other manufacturers to produce drugs, which gives researchers the initiative "As soon as pharmaceutical companies hear about our R & D progress, they take the initiative to contact and request to become our manufacturers." A person in charge of a pharmaceutical research and development organization told reporters that the drug listing permit holder system will have a subversive impact on the entire pharmaceutical industry, many new drug certificates that have been ignored will be activated, and more research and development forces will flow into the field of new drug research and development The R & D personnel have the right to supervise the whole production chain "There is a saying in the drug R & D Industry: the drugs sold, the baby carried out." Liu Changfeng told reporters that in the past, once the research and development results are sold to the manufacturers, the research and development institutions or personnel have no right to interfere in the production links of the manufacturers However, many factors involved in drug production, such as raw and auxiliary material standards, production environment, etc., will have a significant impact on the product quality of drugs "In the past, even if it was thought that the production conditions were not standardized, interference could not be enforced." A R & D personnel told reporters that drug manufacturers do not necessarily fully understand the pharmacology and toxicity Only according to the approved process prescription and under the guidance of the R & D personnel, the drug quality can be more guaranteed This kind of guarantee is strengthened by the system of drug marketing license holder According to the pilot regulations, the holder is mainly responsible for the quality of the whole life cycle of the drug, which enables the drug R & D institutions and R & D personnel to supervise the whole production chain "In fact, some pharmaceutical companies have required that they only take responsibility for production links, while the holders of raw materials, auxiliary materials and packaging materials are responsible for purchasing." Some insiders said that under the drug listing license holder system, the role of drug manufacturers will be limited to "OEM", and the safety of drug production will be controlled from the source of research and development "In the future, the division of labor in the pharmaceutical industry will be more refined." Guan Wenjie, the head of Chengdu new HENGCHUANG pharmaceutical industry, said that in the future, pharmaceutical enterprises will no longer be large and complete, but small and refined, and highly specialized cooperation will be realized in drug development, production and sales "The implementation of the drug listing license holder system will be a" property right revolution "in the pharmaceutical industry According to the person in charge of Sichuan food and drug administration, in order to accelerate the "implementation" of the drug listing permit holder system, Sichuan has successively issued policies such as the implementation plan for the top ten key pharmaceutical R & D institutions and the implementation plan for the early intervention of new drug R & D According to the above policies, Sichuan will open a "green channel" for the review and approval of innovative drugs For major innovative drugs, first generic drugs, and clinically urgently needed varieties, on the premise of no reduction in standards and procedures, Sichuan will intervene in advance, and accelerate the incubation of new drugs for listing through on-site office work, policy and technical guidance, centralized verification and other links such as new drug application and on-site inspection At the same time, we should establish a mechanism for innovation and assistance of pharmaceutical institutions, focus on innovative platforms and emerging industries, focus on new technologies and equipment such as cell therapy, gene therapy and precision medicine, support the construction of pharmaceutical maker platforms and clinical trial institutions in pilot demonstration areas, and strengthen the service and guidance for the development of innovative drugs and the standard setting of manufacturing enterprises "The location advantage of the pilot demonstration area will become more and more obvious." Chen Jing said that at present, Wenjiang district is speeding up the construction of Chengdu medical city according to the city's planning The favorable policies formed by the listing permit holder system have attracted a lot of investment and scientific research forces for the medical city, and will realize the industrial scale of hundreds of billion yuan by the end of the 13th five year plan According to the person in charge of the relevant departments of Sichuan food and drug administration, each pilot area has designated a liaison person, so as to provide policy consultation, data filling and technical guidance for the application of enterprises, and encourage each pilot area to build a technical platform and service platform to meet the scientific research needs of research and development institutions Hu Wei, Secretary of the Party Working Committee of Yuechi Economic Development Zone, one of the pilot areas, said that the park has attracted more than 10 enterprises and scientific research institutions in Chongqing, Guangdong, Jiangsu and other places "Because only Sichuan is selected as the pilot in the central and western regions, many medical researchers, institutions or enterprises in neighboring provinces want to bring achievements to Sichuan for incubation and enjoy the benefits of the new deal."