The development situation of pharmaceutical industry is getting better, continue to play a leading role

[market analysis of China Pharmaceutical network] 2016 and 2017 are the year of pharmaceutical policy Under the background of continuous downward pressure from industry, the development situation of pharmaceutical industry is obviously better Among them, the growth rate of industrial added value, profit, export delivery value and other major economic indicators have rebounded to varying degrees, and continue to play a leading role in various industries (picture source: Baidu picture) it is estimated that in 2017, with the recovery of the growth rate of the pharmaceutical market in developed economies and the strong demand of the pharmaceutical market in emerging economies, China's pharmaceutical industry will continue to recover under the promotion of domestic health consumption upgrading and a number of policies The development of the pharmaceutical industry continues to improve into 2017, and the domestic and international environment for the development of the pharmaceutical industry in China will be significantly improved On the international side, the growth rate of the pharmaceutical market in developed economies has picked up, the market demand in emerging economies is strong, and the proportion of biotechnological drugs and chemical generic drugs in the drug structure has increased The strategy of "one belt, one road" has been comprehensively promoted, bringing new opportunities for China's pharmaceutical industry export, structural adjustment and enterprises' "going global" On the domestic side, the supply side structural reform has been promoted in an all-round way, the state's policy support for the pharmaceutical industry has been strengthened, the awareness of national health and prevention and protection has been strengthened, the two child policy has been implemented in an all-round way, and the disposable income of residents has been steadily increased, including the made in China 2025, the outline of healthy China 2030 plan, the guideline for the development of the pharmaceutical industry and the "three products" war Major strategies and plans have been implemented successively All of these will boost the development of China's pharmaceutical industry and promote the development of the pharmaceutical industry to continue to pick up On the one hand, optimizing the organizational structure is an important task of the guideline of pharmaceutical industry development planning According to the guidelines for the development planning of the pharmaceutical industry, during the 13th Five Year Plan period, the standards for registration, quality, energy conservation, environmental protection and safety production will be improved, the compulsory cleaner production audit will be increasingly strict, the green transformation, merger and reorganization will be carried out in an orderly manner, the national efforts for haze control will continue to increase, and the new production capacity of some fields, especially the environmentally sensitive chemical APIs, will be effective Control, the existing relatively backward production capacity will gradually exit On the other hand, the consistency evaluation of quality and efficacy of generic drugs has been comprehensively promoted A large number of small and medium-sized generic drug manufacturers and some large-scale pharmaceutical enterprises will gradually withdraw or give up production of some varieties subject to high evaluation costs The results of the two functions will effectively improve the organizational structure of the pharmaceutical industry, the status of large and medium-sized pharmaceutical industry enterprises will be further prominent, and the industrial concentration will be increased In addition, enterprise innovation is more active Biomedicine and high-performance medical devices are important areas of planning support for development, such as "made in China 2025", "outline of healthy China 2030 plan", "guidelines for pharmaceutical industry development plan", "industrial technology innovation capacity development plan (2016-2020)" Several opinions on carrying out the "three products" special action of consumer goods industry to create a good market environment clearly pointed out that it will support the development of health consumer goods such as rehabilitation aids, fitness products, intelligent medical products, etc., "major new drug creation", "research and development of digital diagnosis and treatment equipment", "prevention and control of major infectious diseases such as AIDS and viral hepatitis" and other national science and technology plans Special projects such as industrial transformation and upgrading continue to increase support for biomedicine and high-performance medical devices, and the registration and approval of innovative drugs and medical devices continue to improve The strong guidance of the plan and the strong support of the policy point out the direction for the technological innovation of the enterprise, which will greatly stimulate the innovation vitality and innovation power of the enterprise The three bottlenecks need to be solved First of all, the cost pressure faced by pharmaceutical enterprises will be further increased in 2017 More than 90% of pharmaceutical enterprises will be impacted by the promotion of quality and efficacy evaluation of generic drugs According to industry estimates, the evaluation cost of a variety is about 6 million yuan Small and medium-sized pharmaceutical industry enterprises are weak and can not bear the high evaluation cost For large enterprises, because there are dozens or even hundreds of varieties involved, the evaluation cost is also difficult to bear With the improvement of energy-saving, environmental protection and safety production standards and the increasingly strict mandatory cleaner production audit, the environmental costs faced by enterprises can not be ignored The shortage of APIs, intermediates and traditional Chinese medicine leads to the price rise, and the disappearance of demographic dividend indirectly increases the production cost of downstream enterprises in the industrial chain Secondly, the problem of drug supply security has become increasingly prominent in recent years In 2017, influenced by policy and market failure, the fluctuation of drug supply may be further intensified The overall promotion of generic drug conformity assessment will have an important impact on the supply of some clinically necessary and irreplaceable drugs and low-cost drugs Under the influence of multiple factors such as the profit space of the drug itself, the strength of the enterprise and the cost of evaluation, some enterprises may voluntarily give up the consistency evaluation of the quality and efficacy of some varieties and then stop production The risk of market supply interruption cannot be ignored With the increasing pressure of environmental protection, the continuous increase of national efforts to control environmental pollution and the continuous improvement of emission standards, some chemical drugs, especially API production enterprises, may be limited (stopped) due to the non-compliance of emissions, and some drug production and market supply problems will occur, which will inevitably lead to market shortage Measures such as drug bidding and purchase, reduction of drug proportion, medical insurance and fee control will further squeeze the profit space and market space of some prescription drugs, especially children's drugs with market failure and drugs for rare diseases, resulting in the unprofitable production of some drugs and production suspension, and market shortage or aggravation Third, in recent years, although the quality of domestic medical equipment and consumables continues to improve, some consumables have reached or exceeded the level of developed countries, and the country has also issued the first set of insurance Policies such as compensating pilot projects and controlling unreasonable increase of inspection costs of medical institutions are adopted to encourage the application of domestic medical devices, especially large-scale medical devices However, domestic medical devices are ignored in China's market due to policies, concepts and other reasons, and "import substitution" has little effect The number of imported medical devices, especially high-performance medical devices, is regarded as an important reference index in the hospital rating process In the context of the continuous promotion of the new medical reform, the pressure of hospital competition is increasing, and the desire for "promotion" of hospitals for survival will be stronger Affected by this, the tendency of public hospitals to purchase imported medical equipment will be further strengthened, and the situation of domestic medical equipment being neglected is hard to be fundamentally changed In order to reduce the medical risks in the use of equipment, most hospitals blindly worship imported equipment, but do not pay attention to the relevant technical quality indicators There are many non-compliance behaviors in the purchase of medical devices In the purchasing process of some units, the requirements of parameters and indicators are often taken as the important elements of purchasing equipment, which makes it difficult for domestic medical equipment to be shortlisted In view of these five countermeasures and suggestions, CCID think tank put forward suggestions such as increasing policy support, practically improving the ability of drug supply guarantee, promoting green and intensive development, and strengthening the operation, monitoring and management of the industry And increase policy support The first is to strengthen the coordination of the quality and efficacy consistency evaluation of generic drugs, and give a transitional period for the consistency evaluation of some difficult and high cost varieties to reduce the cost pressure of enterprises It is suggested that the consistency evaluation of quality and efficacy of generic drugs should be included in the scope of support of relevant national and local special funds in 2017, and the research expenditure of generic companies actively purchasing reference preparations should be included in the scope of value-added tax deduction Further tax incentives Coordinate all kinds of financial institutions, increase the credit line to carry out the consistency evaluation of quality and efficacy of generic drugs for relevant key generic enterprises, reduce collateral requirements, and improve risk tolerance Second, we will conscientiously implement the relevant national policies on the deduction of value-added tax for high-tech enterprises, small and medium-sized micro enterprises, newly purchased equipment, accelerated depreciation of fixed assets, phased reduction of social insurance premiums and other policies to reduce the burden on the real economy, eliminate all unreasonable charges and fees, and effectively reduce the burden on pharmaceutical enterprises Third, we will improve the centralized drug purchase policy, promote "quality price consistency", cancel the price protection system for original research drugs, and give generic drugs the same bid winning policy through consistency evaluation Fourth, we will continue to increase policy and financial support for independent innovation, new product development, green development, intelligent manufacturing and other aspects of pharmaceutical industry enterprises, further optimize the registration and approval process, and stimulate the vitality of enterprises Second, ensure the supply of drugs First, focusing on the problems of low-cost drugs, clinical drug shortage for children and import dependence of drugs for some rare diseases that have been strongly reflected by the society in the past two years, we will continue to organize the production of key backbone enterprises in the form of designated production or entrusted production, so as to ensure the market supply and product quality Second, we should give full play to the improvement of the national pharmaceutical reserve system, strengthen the interconnection and linkage between national and local reserves, increase the pharmaceutical reserves with high market shortage, large demand and obvious price fluctuation, optimize the physical reserve structure, enrich the reserve mode, and increase the technology, production capacity and information reserves The key point is to combine the quality and efficacy consistency evaluation of generic drugs, and moderately increase the physical and capacity reserves of drugs that may cause insufficient market supply due to the evaluation Third, according to the form of market demand, we should give full play to the role of import emergency regulation, and moderately increase the temporary import of drugs with insufficient market supply Third, more efforts should be made to promote the application of domestic medical devices First, strengthen departmental coordination, continue to promote the demonstration project of medical equipment application, form a group of consortiums with the participation of enterprises and influential hospitals, promote the demonstration application of a group of domestic medical equipment in medical institutions, cultivate a group of medical institutions to become the demonstration base of domestic medical equipment application, and form a good "application evaluation feedback improvement level improvement radiation promotion" Sexual cycle Continue to carry out the pilot work of the first (set) major technical equipment insurance compensation mechanism, promote the cooperation between large-scale medical equipment enterprises, financial leasing companies and financial leasing companies, and promote the application of new medical equipment Second, taking the new round of medical reform as an opportunity, we will fully implement the opinions on controlling the unreasonable growth of medical expenses in public hospitals, and vigorously promote the selection of domestic high-performance medical diagnosis and treatment equipment It is suggested that the proportion of domestic brands with good stability and reliability should be made clear in the total amount of Chinese medical equipment purchased at the end of the year Third, we will take the opportunity of comprehensively promoting classified diagnosis and treatment, increase the promotion and support of domestic three types of medical devices, increase the application proportion and market share of domestic medical devices in primary medical institutions, and gradually realize the penetration into medical institutions in large and medium-sized cities Fourth, take the opportunity of the national "three products" special action of consumer goods industry, guide and local medical equipment enterprises to carry out new minimally invasive activities focusing on quality standards and benchmarking, strive to solve the reliability and stability of domestic medical equipment, and strengthen the establishment and cultivation of independent brands of domestic medical equipment Fourth, promote green development in an all-round way First, strengthen the awareness of energy conservation and environmental protection of enterprises, and introduce