Medical network - on April 12, 2016 was "much starker choices-and graver consequences-in" the start of the implementation, pharmaceutical industry vigorously implement the strategy of innovation, advancing a supply side structural reform, actively adapt to the new normal economy, the industrial downward pressure continues unabated, against the background of the development situation is significantly positive, industrial added value, profit and export delivery value of economic indicators such as the growth in different degree, continues to play a leading role in the industrial sectors. Medical market growth is expected in 2017, as developed economies rebound, medicine market strong demand from emerging economies, in domestic health consumption upgrades as well as a number of policy, China's pharmaceutical industry will continue warming trend. 

 

Pharmaceutical industry development continues to improve 

 

In 2017, our country the development of the pharmaceutical industry facing the domestic and international environment will be improved significantly. The international aspect, the developed economies medical market growth picks up, strong demand in emerging economies and biotech drugs and chemical generics proportion increase in drug use structure. "Area" strategy comprehensively advancing, for the pharmaceutical industry in our country export, structural adjustment and enterprise "going out" brings new opportunities. Domestically, the supply side of structural reforms comprehensive advancement, the country of the pharmaceutical industry policy support rising, the national health and prevention to enhance protection consciousness, comprehensive two child policy implementation, disposable income increased steadily, "made in China 2025", "health program for China's 2030, the pharmaceutical industry development planning guide and the strategy of" doctrine "and other major strategic and planning implementation. All these will boost for pharmaceutical industry development in our country, promote the development of pharmaceutical industry continue to rebound. 

 

On the one hand, the optimization of organizational structure is the pharmaceutical industry development planning guide is an important task. In accordance with the pharmaceutical industry development planning guide ", "much starker choices-and graver consequences-in" during registration, quality, energy saving, environmental protection, production safety standards will be improved, such as mandatory cleaner production audit will become increasingly strict, green transformation and orderly promote merger and reorganization, governance haze strength continues to increase, especially the environmental sensitivity in the field of chemical API new capacity will be effectively controlled, the existing relatively backward production capacity will gradually withdraw from. Consistency of generic drugs, on the other hand, the quality and curative effect evaluation of comprehensive advancement, a large number of small and medium-sized generic drug production enterprises and some big pharmaceutical companies under the control of the evaluation of high cost will gradually quit or give up part of the varieties of production. Two aspects of the role of the results will effectively improve the organizational structure of the pharmaceutical industry, the status of large and medium-sized pharmaceutical enterprises will further highlight, industrial concentration will be increased. 

 

In addition, the enterprise innovation more active. Biological medicine and high performance medical devices are "made in China 2025", "health program for China's 2030, the pharmaceutical industry development planning guide, the industry technology innovation ability development planning (2016-2020)," such as the national planning and support the development of the important fields. "About to carry out the consumer goods industry" the doctrine of "several opinions on special action to create a good market environment that will support the rehabilitation equipment, health products, intelligent medical products such as the development of consumer health class," major drug discovery ", "digital medical equipment research and development", "prevention and control of major infectious diseases such as AIDS and viral hepatitis" such as the national science and technology plan, industrial transformation and upgrading of the special support of biological medicine, high-performance medical equipment continues to increase, and improving innovative drug and medical device registration approval. Powerful guidance for planning and policy pointed out the direction of the powerful support for the enterprise technology innovation, will greatly inspire the innovation of the enterprise vitality and innovation power. 

 

Three big bottleneck to crack 

 

First of all, the pharmaceutical industry enterprises in 2017 will further intensify the pressure on costs. Generic drug quality and curative effect evaluation comprehensively promote consistency, more than 90% of the pharmaceutical industry enterprises will suffer. According to industry estimates, a variety of evaluation costs about 6 million yuan. Small and medium-sized pharmaceutical enterprise is weaker, the evaluation of high cost. For big business, because involves have dozens or even hundreds of varieties and appraisal costs also unbearable. Energy saving, environmental protection, production safety standards and increasingly strict mandatory audit of cleaner production, the environmental costs of companies face the same can not be ignored. Active pharmaceutical ingredients, intermediates, shortage of Chinese medicinal materials lead to price rise, and the disappearance of the demographic dividend also indirectly increase the industry chain downstream enterprises of the cost of production. 

 

Second, drug supply security is increasingly prominent in recent years. In 2017, under the influence of policy and market failure, drug supply fluctuations or will worsen. Comprehensively promote the generics consistency evaluation of parts for clinical necessary and irreplaceable drugs and drug supply at low prices have important influence. Subject to drug itself profit space, the enterprise strength, the influence of multiple factors such as appraisal costs, some companies may take the initiative to give up part of the quality and consistency of curative effect evaluation, in turn, production, market supply risk can not be ignored. Growing environmental pressure, the country's efforts to control environmental pollution continues to increase and the continuous improvement of emission standards, it may cause chemical medicine, especially API manufacturing enterprises for below-standard emissions limits (stop), part of the production and supply of the drug problem will appear, the market shortage or will be inevitable. Drug bidding procurement, to reduce the medicine proportion, health control measures such as cost, there will be further squeeze some prescription drugs, especially children, rare diseases, use of market failure of profits and market space, cause drug production unprofitable and production, market shortage or will intensify. 

 

Third, in recent years, although the domestic medical equipment and consumables of continuous quality improvement, part of the consumables are close to or exceed the level of developed countries, the country also launched the first sets of insurance compensation pilot, control, check medical institutions such as higher expense unreasonable policies to encourage domestic medical apparatus and instruments, especially the application of large medical equipment, but is subject to reason, such as policy, concept of domestic medical device market in our country were snubbed, "import substitution" with little success. Import medical instrument quantity, especially the high performance of medical equipment in the process of hospital ratings were used as important reference index. In promoting continuously under the background of the new medical reform, the hospital competition pressure, in order to survive a hospital "promotion" desire will be more intense. As a result, the tendency of public hospitals purchasing imported medical equipment will be further strengthened, and the situation of domestic medical device is hardly a fundamental change. Most hospitals in order to reduce the medical risk of equipment in use process produce, blind worship of imported equipment, and do not pay attention to the related technical quality indicators. Medical equipment procurement procedures have many don't compliance behavior. Part of the unit in the process of purchasing as parameters and indicators, and often require as purchasing equipment requirements, lead to domestic medical equipment for hard. 

 

Five countermeasures and Suggestions 

 

In view of this, sadie, a think-tank, puts forward the intensify policy support, drug supply to ensure and improve the ability, promote green intensive development, strengthen industry operation monitoring management. 

 

First, strengthen policy support. One is to strengthen the quality of generic drugs and curative effect evaluation of consistency of coordination for part of the evaluation is difficult, the cost is high consistency evaluation suggest giving a transition period to reduce the enterprise cost pressure. Recommendations will be generic quality consistency and efficacy evaluation in 2017 national and local related special funds to support category, will be generics companies take the initiative to choose and reference preparation research spending included in the VAT deduction scope, for major disease medicine, children's medicine, shortage of rare disease medication, medicine and tax rate significantly higher, import demand elasticity larger important API further tax reductions, etc. To coordinate all kinds of financial institutions, increase of related key generic drug companies to carry out the quality of generic drugs and curative effect evaluation of consistency credit, reduce collateral requirements, improve risk tolerance. Second, earnestly implement the relevant national high and new technology enterprise, micro, small and medium enterprises, new equipment, VAT deduction, accelerated depreciation of fixed assets, periodically to reduce social insurance rates, and other relevant policies reduce the burden of the real economy, to cancel all the unreasonable charges and fees, lightens the burden of pharmaceutical enterprises. Three is to improve drug centralized purchasing, and push the price "consistent", cancel the original medicine price protection system, equal bidding policy for through consistency evaluation of generics. Four is continuing to increase medicine industrial enterprise independent innovation, new product development, green development, intelligent manufacture and so on aspects of policy and funding support, further optimize the registration approval process, stimulate the enterprise vitality. 

 

Second, ensure drug supply. A is around two years social reflect the strong low medicine, clinical medicine for children shortage and some rare disease drug import dependence, continue to designated production or entrust production key leading enterprise organization form of production, ensure market supply, ensure the quality of the product. Second, give full play to improve the national pharmaceutical reserve system, strengthen the national reserves and local reserves of connectivity and linkage, increase market shortage degree is high, the demand is bigger, the price fluctuation of medication and optimize the structure of physical reserves, rich reserves, reserves increase capacity technology, and information. Focus is combined with the generic quality and curative effect evaluation of consistency, a modest increase may be caused by evaluation the physical supply of medicines on the market, reserve capacity. 3 it is to form according to market demand, give play to the role of import emergency adjustment, a modest increase in market supply of temporary import drugs. 

 

Third, for advancing the domestic medical equipment application. One is to strengthen the department coordination, continue to push forward the high-end medical equipment application demonstration projects, forming a number of enterprises and influential hospitals to participate in a consortium, promote a batch of domestic medical equipment demonstration application in medical institutions, foster a batch of medical institutions become the domestic medical equipment application demonstration base, forming "application evaluation, feedback improvement - level - radiation promoted" the virtuous cycle. Continue to conduct the first (set) pilot work, major technical equipment insurance compensation mechanism to promote large-scale medical equipment companies and financial leasing companies, financial leasing companies, promote new medical equipment application. Second is a new round of reform as an opportunity, the full implementation of "about control public hospital medical expense unreasonable growth of several opinions, promote the selection of domestic high performance equipment for medical diagnosis and treatment work. Suggestions in the annual national terminal purchasing high-end medical equipment total clear stability, reliability, good the proportion of domestic brands. Three is advancing a hierarchical diagnosis and treatment as an opportunity to increase publicity and promotion and support for domestic three kinds of medical apparatus and instruments, improve the domestic high-end medical equipment in the application of grassroots medical institutions in the scale and market share, and gradually achieve to the penetration of urban medical institutions. Four special action state to carry out the "doctrine of" consumer goods industry as an opportunity to guide and local medical equipment enterprises to the quality standard, the standard of innovation activities, strive to solve the domestic medical equipment reliability, stability, strengthen the domestic medical equipment independent brand creation and cultivation. 

 

Fourth, promoting green development. One is to strengthen enterprise energy conservation and environmental protection consciousness, and guide enterprises in new environmental laws, the article 10 of "water" and related regulations and the relevant policy study, efforts to improve environmental comprehensive control of consciousness. 2 it is to guide and encourage local to strengthen the construction of medical professional park, guide for active pharmaceutical ingredients and pharmaceutical intermediates production enterprises city back into the garden, building green intensive medical circular economy industrial park. Guide the whole process of enterprise application allowed emissions reduction technology, strengthen the enterprise's technical transformation, in accordance with the production cycle, make green plant with advanced production technology and process. Three is to encourage enterprises to introduce automatic intelligent clean new equipment and equipment, to carry out the automatic and intelligent transformation, improve the level of the production process automation, intelligent, reduce resource waste, improve production efficiency and resource utilization ratio. 

 

Fifth, strengthen industry operation monitoring and development guidance. One is running monitoring platform we will accelerate the establishment of a pharmaceutical industry development, strengthen the generics, industry leaders, and children, such as medicine, rare disease medication on the operation of key products and market supply situation, timely find MiaoTouXing, trends, and effectively prevent inconsistency of generic quality and curative effect evaluation work may lead to drug supply fluctuation and market shortage. Second, relying on the related industry intermediary organizations, actively promote "made in China 2025", "health program for China's 2030, the pharmaceutical industry development planning guide and other relevant national planning implementation, strengthen the propaganda and guidance of enterprises. To strengthen the quality of generic drugs and curative effect of consistency evaluation guidance, tracking, timely reflect the enterprise demands. 3 it is to give full play to the think tank of the "extended mind", actively carry out international medical technology innovation, product innovation, the industrial policy, supply side structural reform of track and improve the decision-making support system.