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The five major problems of domestic medicine need to be solved urgently

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  In the first three quarters of this year, the overall situation of China's foreign trade in medicine has been relatively good. The us market and emerging markets such as India and Brazil have witnessed a recovery of growth, which is conducive to the growth of exports throughout the year. Imports are growing at a good pace. However, China encourages the use of domestic large-scale equipment and tenders to reduce drug prices, which will have an impact on the import of large medical equipment and high-priced patented drugs.

  Since the beginning of this year, the global economy has maintained a moderate recovery and the growth of international trade has accelerated. In the field of medicine, although the traditional foreign trade and price competitive advantage, industry competition is intense, but appeared with the development of national policy effect, supporting medical new kinetic energy is speeding up the accumulation of foreign trade development, steadily improving the quality benefit, continue to optimize foreign trade structure, medicine, foreign trade to the good pattern has already formed in steady throughout the year.

  Five major export problems:

  1. The competition of API is disordered

  China has vigorously promoted supply-side structural reform and made progress in recent years, but the problem of overcapacity in bulk API is difficult to solve in the short term. In the face of fierce market competition, the export price of bulk API has been declining all the way. Enterprises have been fighting a price war for the market, and the profit space has been continuously squeezed. At the same time, the domestic part of the small API for manufacturers, low yield, less exists monopoly price or be circulation, agents manufacturers exclusive buyout situation, lead to other preparations manufacturers have to high-priced goods, then push the export prices. Some pharmaceutical companies have abandoned market segments such as cimetidine, lidocaine and oxytocin because they are out of stock.

  2. Environmental pressure

  First, a large number of pharmaceutical companies are facing the dilemma of stopping production due to environmental protection problems. Such as zhejiang taizhou there are several pharmaceutical intermediates business closures of Beijing requires API production enterprise in heating season in November at all before the move, beijing-tianjin-hebei pharmaceutical industry in heating season wrong peak production, etc.

  Second, pollution standards in the pharmaceutical industry have been gradually raised. The revised edition of the standards for the emission of atmospheric pollutants in the pharmaceutical industry refers to the experience of Europe, the United States, Japan and other countries, and adopts the emission permit system, some of which are more stringent than developed countries.

  Third, the long-term production suspension of enterprises leads to the shortage of domestic supply of related products, and some international orders cannot be normally executed, which directly faces the risk of economic compensation and market loss.

  There are places to look for a "one size fits all" approach. For example, some leading pharmaceutical companies in hebei have invested huge sums of money in environmental protection upgrading and transformation. Although they have met relevant requirements, they are "treated as equals" with enterprises that fail to meet the environmental protection standards in the face of production suspension and restriction measures.

  3. Weak innovation ability

  Recently, the medical insurance chamber investigated some economic and technological development zones, medical industrial parks and related enterprises. Although all places attach great importance to scientific and technological innovation, there are still some problems such as insufficient investment and serious homogeneity of enterprise products. In some enterprises, the r&d cost of products is even less than 1% of the total sales revenue, far lower than the r&d input ratio of advanced countries. Part by the open area, the industrial park is located in the Midwest, high level research and development resources are relatively scarce, relative lack of high-level r&d talents, science and technology innovation base is relatively weak, lack of high quality to attract top talent, venture capital element agglomeration platform carrier, enterprise innovation and research and development ability is not strong, independent intellectual property rights and less well-known brands, innovative leading enterprises are rare.

  4. Difficulty in drug registration and certification

  The long review period of new drugs is a prominent problem in the industry. At present, it still takes 5 to 8 years for an imported drug to be registered. In addition, the international registration of drugs requires a large amount of manpower and financial resources, and the registration and certification in relevant countries has a short period of validity and a high cost. For example, meiyukang of gansu reflects that the Australian (TGA) certification period is short, with only a two-year validity period, and the certification costs are high, with each product reaching 400,000 to 500,000 RMB/time. Lanzhou Keats feedback product registration due to identity, different countries, the cost of a single variety from thousands of dollars to tens of thousands of dollars.

  5. The enterprise's international market development is limited by relevant policies

  According to the relevant provisions, in production, processing varieties to record producer of food safety, but only in the importing country as a "drug" to register and obtain approval document, may in the domestic GMP factory production. Proprietary Chinese medicine, for example, it has not been implemented in many countries legislation, the FDA for proprietary Chinese medicine management has always been in accordance with the drug standards, but still classified as "dietary supplement", and therefore does not conform to the stipulations of the China for the record, affect the company involved in the business of the United States. In addition, the export agents need to provide the drugs certificate of export sales certificate (CPP), but most of Africa needs drug specifications with different in our country, according to the application for registration in China for the specifications of the foreign and the difficulty of examination and approval, caused our country enterprise cannot undertake this part of the drug orders, to the international market to Europe and the United States and India company.

  Forecast for the whole year: pharmaceutical trade is expected to increase by 10% to 12%

  In the first three quarters of this year, the overall situation of China's foreign trade in medicine has been relatively good. The us market and emerging markets such as India and Brazil have witnessed a recovery of growth, which is conducive to the growth of exports throughout the year. Medical products are exported to nearly half of all export amount of bulk active pharmaceutical ingredients year-on-year growth of 8.86%, the export volume grew 7.04% year-on-year, reflecting the international market is still strong demand for bulk drug substances in our country, and with the domestic environmental law enforcement and tougher, push the export prices of bulk drug substances, such as cardiovascular drugs rose 117.6%, vitamins API rose 18.38%, the overall API exported by the first half of the price has fallen 1.56% to the current rise of 1.7%. However, some enterprises have reported that despite the demand in the market, the domestic supply is difficult due to environmental factors, and the export volume may shrink.

  Imports are growing at a good pace. However, China encourages the use of domestic large-scale equipment and tenders to reduce drug prices, which will have an impact on the import of large medical equipment and high-priced patented drugs. And as the early and the relevant department under the state council to formulate measures of stability, promote foreign trade growth gradually implemented, combined with the recent "about deepening the review the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" on the adjustment of imported drug registration management related matters, such as policy implementation, will be good for medicine, healthy and stable development of foreign trade.

  According to the comprehensive analysis, based on the low base of foreign trade last year, it is estimated that the import and export of pharmaceuticals will increase by 10% to 12%, export by 5% to 7% and import by 16% to 18% in 2017.

  Discussion:

  How to improve the medical trade environment?

  1. Strengthen the regulatory system and strengthen classified control

  To advise the relevant departments on the macro dredge guide, perfect the regulatory measures, through striking JiaLie pharmaceutical products export, contain low malignant competition measures such as timely eliminate quality standards compliance of the enterprises.

  In the field of environmental protection, the policy of "keeping pressure" should be adopted. For enterprises that meet the standards, they may be allowed to operate normally during the heating season or part of the production line. For enterprises that fail to meet the standards, strict measures should be taken to force them to strengthen their investment in environmental protection or phase it out gradually.

  In addition, the normal production of exclusive varieties involving people's livelihood should be allowed. The government should formulate unified pollutant treatment measures and standards so that enterprises can follow the rules. Scientific research institutions should intensify their research in the field of environmental protection technology, guide enterprises to solve related problems and reduce costs.

  2. Cultivate leading enterprises and industrial groups, and attach importance to innovation factors

  The government should increase its support and cultivate enterprises with good economic benefits, strong driving capacity and great development potential as key leading enterprises. We will encourage powerful enterprises to strengthen cooperation, enhance economies of scale, and build industrial clusters with several leading enterprises as the core.

  To guide and encourage innovation resources, at the same time of rational utilization of leading enterprise technical advantage, to build a joint between enterprises innovation platform, relying on the long-term stability of the science and technology innovation cooperation mechanism, promote facility enterprise's technological innovation ability, promote transformation and upgrading of enterprises effectively.

  3. Strengthen the construction of the standards system and accelerate the mutual recognition of international standards

  For enterprises one by one through the actual situation of different countries quality certification cost, should strengthen the communication between government regulations and technical standards consultations, strengthen external representations, promote the international drug standard docking, mutual recognition. Work with the international community on regulatory cooperation to eliminate technical barriers to trade through multilateral and bilateral mechanisms. At the same time, actively participate in the formulation of international standards. Such as health care chamber of commerce has three group of plant extracts formulate and publish international business standards, and achieve good response in the industry at home and abroad, also get the relevant government departments and inspection testing institutions.

  4. Improve the import promotion system and improve trade facilitation

  Relevant departments should attach importance to give full play of the role of pharmaceutical imports in the national import strategy, support for training professional import expo, and through long-term operation, form a complete, professional and strong, large influence in the industry of exhibition brand import; Further simplify and ease some import management measures, to does not conform to the current development of policy to revise and improve, improve the institutions such as customs, commodity inspection, certificate for import links overall coordination.

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