It's dead? Band volume procurement lead the industry change day, experts show consistency evaluation "inside"!

Guide: Rebate-based sales model will end in 3 to 6 yearsJuly, the third batch of drug collection in the country is about to land, the provincial and municipal level of the volume of procurement is also in full swing: in April, Gansu Province officially implemented the second batch of national organization of drug centralized procurement results, the average price of 32 kinds of drugs fell by 6 2%, the highest decline of 89%; in May, Shandong Zibo City Medical Security Bureau launched the seven-city pharmaceutical procurement alliance medical supplies joint procurement bargaining, has become the "largest in the history of Shandong" "cut price super-tough" a negotiation, the highest reduction of supplies for 72%drugs, medical equipment and other sharp price cuts, pharmaceutical companies' original survival space was affected, there are insiders said that through consistency evaluation difficult, through the volume of procurement is even more difficultMore pessimists predict that if the future is not through the consistency evaluation, pharmaceutical companies are likely to stop production, or even exit the marketso, so that countless pharmaceutical companies to smell the wind of the imitation of the drug consistency evaluation, 4 plus 7 band volume procurement, how to deal with it? Pharmaceutical intelligence interview special interview with domestic preparation field senior expert Sun Asia, for everyone to see the consistency evaluation of the "inside."senior expert sorority in the field of domestic preparations,CFDA Institute of Advanced Studies Special Lecturer Sun Asiaconsistency evaluation and volume procurement
the pharmaceutical industry "revolution""imitation drug consistency evaluation, 4 plus 7 band volume procurement will have a huge impact on the future of pharmaceutical companies" Sun Asia analysis, the pharmaceutical industry is related to people's right to life and health, and these two policies will play a key roleuniversal health insurance is a certain stage of economic and social development, the product of the requirements, is the most basic requirements of people-oriented, "some third world countries have achieved universal health insurance, and China claims to be the world's second largest economy, how to achieve universal health insurance, is an urgent matter"
is now, the Chinese mouth volume is huge, universal health insurance will inevitably lead to the problem of health insurance costs, in order to meet the problem of universal health insurance, we must reform the sales mode of "kickback" as the main marketing channel, change the current situation of false high drug prices, drug price reduction is unstoppable, "one of the means to achieve price reduction is drug supply." The report of the 19th National Congress of theParty pointed out that the growing needs of the people should be constantly metThe first thing to do is to ensure the health of the people in order to enjoy the fruits of social reform"For the sake of people's needs, one of the means by which the quality of medicines must be raised is the evaluation of generic consistency."the National Health Insurance Administration to actively explore, learn from the United States market competition model, plus the Japanese government unified pricing model, to study the "Chinese characteristics" of the Chinese model, that is, consistent evaluation and volume procurement policy The reduction of drug prices and consistency evaluation of the volume procurement will be the overall trend of the pharmaceutical industry all over the world, so as to improve the quality of the drug, and to realize the reform of the pharmaceutical industry and ensure the health of the people double policy, these pharmaceutical companies are doomed to be eliminated! , according to Pharmaceutical Intelligence Media, in 2016-2018, less than 10% of the varieties completed the consistency evaluation In this regard, Sun Asia said: "Before 2018, the pharmaceutical industry in the confused stage, on the one hand, because the pharmaceutical industry leaders did not really appreciate the strong will of the national leaders in the pharmaceutical industry reform, satisfied with the status quo, stubbornly self-proclaimed, but also think is through the field, blowing the wind, these pharmaceutical companies are doomed to be eliminated." Sun gave his opinion on which pharmaceutical companies will be eliminated under the country's dual-drug policy first, do pharmaceutical companies must have feelings , pharmaceutical companies for people's health to do services, can not be a mind thinking only money Many pharmaceutical leaders are "outsiders", including outsiders who want to make money from them, "not in accordance with the laws of scientific development of the industry to do things pharmaceutical companies, must be eliminated." "
second, emotional but too weak enterprises There is a threshold for the pharmaceutical industry, not any small business owner can "play around" "The enterprise, early exit, for their own, health industry, are not harmful." at present, some do not understand the pharmaceutical companies want to improve the drug market process, 100% successfully passed the process to achieve commercialization, while the research and development institutions in order to rob the project, under the cover of BE," "bao take production approval" under the guise, to attract pharmaceutical companies commissioned the improper demand of pharmaceutical companies determines the unfair market competition of research and development, which becomes a common market mess "Commitment simply on the refund, the use of bad means to compete, from a scientific point of view is the principal of the fraud." Sun Explained, "If you don't follow the laws of science, do research and development, will soon be eliminated." "
consistency evaluation and volume procurement the five major changes in drug research and development thinking
at present, under the dual policy, there is a huge conceptual difference between drug research and development and production system, resulting in the pharmaceutical sector cut-off, development difficulties." Research and development personnel thinking active, and constantly use new ideas, methods to solve the problem, and the production system to pursue stability, duplication of production conditions, resulting in a natural opposite contradiction "New thinking is needed to address the development of pharmaceutical companies in response, he said drug research and development must change from five aspects 1, industrialization awareness drug research and development from the initial project of each project to start, from start to finish in the commercial production of the height of "over-view" to guide the entire product from project research, laboratory research and development, pilot amplification to the whole process of large-scale production 2, the efficacy is consistent the research and development of solid preparation generics should be transformed to the height of clinical efficacy or BE equivalent as the evaluation endpoint, "overlooking" to guide the whole pharmacological consistency evaluation study, that is, BE or clinical equivalent is "gold standard" 3, comprehensive costs every link of the entire industrial chain should establish a deep bone marrow cost awareness, standing in a comprehensive, comprehensive consideration of the high degree of saving every millipercent of costs, improve part of the competitive advantage 4, research and development to carry out technological revolution - into the era of industry 4.0 chemical synthesis, preparation production is not a simple double-amplification of the original production mode, but under the industrial 4.0 revolution of high safety, green environmental protection, automation and continuity, stable quality of mass production For example, drug synthesis micro-channel reactor: continuous production, than ordinary reaction tank to save a large number of materials, temperature reduction of 2-10 times, solvents, such as reduced dozens to hundreds of times, a hundred square meters of normal room annual output of dozens to hundreds of tons; 5, research and development concept and production concept integration their own ideological attitude, must not promote the development of pharmaceutical companies, and with a holistic thinking of pharmaceutical companies, must be in the forefront Sun Asia said that pharmaceutical companies should stand on the scientific law, seriously do pharmaceutical research and development, under the support of relevant national policies, the pharmaceutical industry will be the survival of the fittest shuffle speed up, but also have better development, conducive to the health of ordinary people, to achieve the ultimate goal of policy reform Expert introduction : Sun Asia, a senior expert in the field of domestic preparations, a special lecturer and associate researcher of the CFDA Institute of Advanced Studies In drug research and development projects, api, preparation and quality research have extensive experience More than 300 solid preparations were directed from medicine to BE throughout the study, of which dozens have been approved for consistency evaluation