21 major concerns of the pharmaceutical industry in 2014

Source: Pharmaceutical Economic News December 9, 2014 according to the statistics express, the added value of the pharmaceutical industry in 2013 increased by 12.7% year on year, down from 14.5% of the previous year, but higher than the national industrial average of 3.0 Percentage points, in the forefront of various industrial categories, accounting for an increasing proportion of the overall industrial added value; the absolute value of industrial output value and profit also increased significantly, but the growth rate was slower than last year The implementation of the new health care reform was announced in 2009 Until 2013, it is full of variables and challenges Many policies will continue to ferment in the next few years, or even change the pattern of the whole industry So how will the pharmaceutical industry develop in 2014? The author of this paper makes a penetrating comment on 21 "pure dry goods" that affect the industry trend in 2014: ten industries focus on 1 The ownership of the medical reform office: which department the medical reform office of the State Council ultimately belongs to is a matter of concern The quality of the top-level design is related to the degree of cooperation between various departments of the government, and more to the progress and depth of the implementation of the new medical reform 2 New GMP: the new GMP will be pushed forward unswervingly, which will cause a large number of enterprises to stop production, close down or be merged In addition, inflation and rising pharmaceutical costs will make many manufacturers face a difficult year 3 Zero price difference of drugs: the policy of zero price difference of drugs has been gradually expanded throughout the country, and the investment of local government subsidies to hospitals may be more than enough, especially in underdeveloped areas 4 Government subsidies to hospitals: the subsidies to hospitals should be changed from the original three to two The medical institutions are short of money, especially after the full promotion of zero difference rate If the government subsidies are not in place, it is inevitable that the medical institutions will reach out to the pharmaceutical enterprises in the weak side of medical reform 5 Anti commercial bribery: Although anti commercial bribery is normalized, it is difficult to fully comply at present Enterprises try their best to gradually change and break through the sales model There is a lot of debate about the right and wrong of pharmacy trusteeship, and it remains to be seen how to settle it in the future 6 Catalog coordination: the low-cost drug catalog of the national development and Reform Commission and the base drug catalog of the national health and Family Planning Commission need further coordination The new medical reform has been improved and improved gradually, and the corresponding policy changes will cause changes in the medical environment to a certain extent 7 Drug bidding: the bidding work in each province has been promoted slowly, and most provinces and cities are in wait-and-see state The advantages of original research drug bidding still exist, and the competition with generic drugs is more intense Up and down linkage or left and right linkage is one of the concerns of enterprises 8 Drug approval: the process of drug approval is slow In 2014, there will still be a long line waiting for drug registration, but there will certainly be changes Pay attention to the scope of drugs subject to green channel approval Of course, neither low-level nor high-level repetition is desirable 9 Drug price reduction: it is difficult to prevent the price reduction of drugs Although drug bidding in different regions has changed from the original only low price (such as the recently announced Anhui basic drug bidding scheme), the main idea is to reduce drug prices through drug bidding or rent-seeking and rent-setting How to adjust the price of Chinese patent medicine by the government is still the focus of enterprises 10 Medical insurance reform: the reform of medical insurance payment, the pilot of clinical pathway and the medical insurance fee control system of Haihong medicine will be promoted in a large scale, which will promote more standardized drug use in medical institutions and, to a certain extent, affect the growth of the overall amount of drug use Five policy highlights 1 Revision of the Drug Administration Law: the drug administration law is the parent law of drug supervision, and the new drug administration law is expected to accelerate the development and marketing of generic drugs in China and improve the detection period of new drugs Pharmaceutical companies generally expect the new law to be able to revise the drug listing licensing system and drug approval mechanism The new "Drug Administration Law" will make the retail chain operation, third-party logistics, drug export, auxiliary material management, drug recall and other fields more law-abiding 2 Three Guarantees in one: on February 7 this year, the State Council held a standing meeting, and decided to merge the new rural social endowment insurance and urban residents' social endowment insurance, and establish a unified national basic endowment insurance system for urban and rural residents The integration of the new rural cooperative medical system and the old-age insurance for urban residents means that the integration of the three insurances is not far away (Anhui Province has completed it ahead of schedule in March 2014) Once the three guarantees are integrated, the gap between the per capita financing level of NCMS and urban residents is likely to narrow, thus stimulating the demand for medicine, which will bring a great increase to the medicine market 3 Pilot project of serious illness insurance: the notice on accelerating the work of serious illness insurance for urban and rural residents (Guo Yi Gai Ban Fa [2014] No 1) issued by the medical reform office of the State Council on February 8 pointed out that provinces that have not yet carried out pilot project of serious illness insurance for urban and rural residents should start the pilot project before the end of June 2014 The pilot project will establish and improve the coordination and promotion mechanism led by the medical reform office and participated by the development and Reform Commission, finance, social security, civil affairs, health and family planning, insurance and supervision departments By the end of 2013, 23 provinces had issued the implementation plan of serious illness insurance, and 120 pilot cities had been determined 4 Encourage social medical service: the medical supply is still tight, and the high load use of beds in hospitals above the second level is slightly relieved, but it still remains high; the national policy encourages social capital to run medical service, and when the private hospitals further implement the medical insurance coverage and the management of professional titles, the private hospitals will usher in a rapid development period From 2008 to 2012, the number of private hospitals increased by 18% annually and the number of beds increased by 19% Considering the government's target of 20% of private hospitals' service volume in 2015, the annual growth rate of private hospitals' patient volume from now to 2015 will be as high as 30% 5 Price mechanism: in the future, the formation mechanism of drug price will focus on several key points: the market decides the price, the government indirectly guides and pays the binding expenses; the core of the mechanism is to rebuild the competition mechanism of drug health; the key point is to mobilize the enthusiasm of the main unit of purchase and use; the three links of pricing, bidding and reimbursement are closely linked Basic drug market: because the supplement of basic drugs in each province exceeds the expectation, the importance of market access in each region is highlighted, which objectively makes the basic drug market scattered and localized The supplement of the basic medicine catalogue is based on the disease spectrum, medication habits and economic payment ability of each region In 2014, the proportion of basic drugs used in level II and level III hospitals will be introduced, and the policy of matching basic drugs will be gradually clear, which will bring the market opportunities of hospitals above level II to increase greatly, which will be the place for brand manufacturers to compete 2 High quality generic drugs: the idea of canceling the super national treatment of the original research drugs in China is basically clear In the future, the focus of price reduction in China should be the original research drugs, and at the same time, the quality consistency evaluation of the domestic generic drugs should be accelerated Strictly according to the dissolution curve and the original research drug or standard product as a reference, the elimination of national products will be very cruel The quality consistency evaluation of generic drugs is also a long-term work, which will be a test for enterprises The market competition will also shift to the competition of brand, scale and strength, which is conducive to the development of brand enterprises and innovative enterprises with good market reputation, especially high-quality generic pharmaceutical enterprises that can do import substitution 3 "Silver economy": on the one hand, the pharmaceutical industry can actively improve the dosage forms, packaging and sales channels of the elderly; on the other hand, it can actively participate in the construction of pension institutions Pharmaceutical enterprises and rehabilitation medical device enterprises should have a greater say in the elderly care industry 4 Paediatric drug use: the introduction of the policy of single second child has directly benefited in the field of medicine, including pregnancy diagnosis, prevention and treatment of infant and child diseases, medical equipment, paediatric drug use, etc In recent years, there may be explosive growth of newborns, which is estimated to increase from 16 million births to nearly 20 million The paediatric drug market is facing greater opportunities From the analysis of the current market situation, there are still many gaps in the children's drug market in China Among more than 3500 kinds of drug preparations, only 60 are for children, less than 2% It is difficult to meet the clinical needs due to the lack of varieties, specifications, dosage forms, and the focus of varieties on the treatment of cold, digestion, anti-inflammatory and other fields, which has become a problem that the children's drug market has to face 5 Medical service: for medical service enterprises, the total revenue of the hospital reached 1.5 trillion yuan in 2012 Since 2013, the acquisition and merger of medical service industry has been growing rapidly Pharmaceutical companies have acquired hospitals in consideration of the integration of upstream and downstream of the industrial chain Private specialized hospitals expand the hospital network through horizontal acquisition, vertical acquisition and expansion, or enter other specialized fields 6 Pharmaceutical equipment: since 2013, the sales volume of pharmaceutical equipment has increased significantly, and the year-on-year growth rate of the industry has increased from about 20% in 2012 to about 30% This shows that the rapid growth of pharmaceutical equipment industry is not caused by industrial trends, but driven by events, that is, benefiting from the new GMP certification In 2014, as the first batch of sterile drug manufacturers have reached the standard, the growth rate of the industry may be lower than that in 2013 However, considering that the number of non sterile drug manufacturers is far larger than that of sterile drug manufacturers, the pharmaceutical equipment industry is still expected to maintain a high growth rate of 25% - 30% in 2014; in 2015, the deadline for reaching the standard is approaching, and the industry may enter the second growth peak Therefore, in the next two years, the pharmaceutical equipment industry will continue to maintain high-speed growth, and the performance of related enterprises will still have a large room for growth.