In the process of integration with the international community, China's pharmaceutical companies have three major shortcomings: First, they lack the ability to obtain access to the international market, especially to regulate market access. Second, there is a general shortage of professionals with experience in international drug market operations, and international marketing. Weak capabilities, the vast majority of companies only do products, do not market, did not really start their own brands in foreign countries. Third, in the process of dealings with international relations, the treatment of intellectual property issues are not fully implemented, often encounter embarrassing conditions. Among them, the protection of intellectual property rights of pharmaceuticals has always been a weak link in the development of pharmaceutical companies in China, and it is also a frequent zone for disputes with foreign companies.

At present, China's pharmaceutical industry as a whole has shown an upward trend in its expansion across the board and has unleashed tremendous potential. At the same time, due to the slow recovery of the international market and the general rise of international trade protectionism, China’s pharmaceutical foreign trade is facing resistance. The difficulties will be exacerbated. The major difficulties and obstacles that China's pharmaceutical industry must overcome are the following:

The negative impact of the international financial crisis and related uncertainties remains

At present, the international financial crisis has yet to show signs of bottoming out. It is widely expected that the global economic growth rate will be between 2% and 3% in 2010. According to IMS statistics, the global pharmaceutical market will perform relatively well in 2010 and will grow by 4% to 6%. The market size will exceed 825 billion U.S. dollars; by 2013, the compound annual growth rate of the global pharmaceutical market will maintain a rate of 4% to 7%, and the market size is expected to exceed 975 billion U.S. dollars.

Although the expectation of the pharmaceutical industry is better than that of other industries, the impact of the crisis cannot be underestimated. In order to reduce costs and improve production efficiency, major multinational pharmaceutical companies generally start to tighten expenditures, reorganize internal institutions, adjust research and development priorities, and suspend new projects. As a result of the overall shrinking international market demand and the tightening of regulatory policies, the pressure on China's pharmaceutical products exports in 2010 is still relatively high. Among them, the trade of proprietary Chinese medicines will continue to have a deficit. Some related health products are used for rehabilitation and The resistance to the export of massage equipment for physiotherapeutic use is also difficult to eliminate within a short period of time. The situation is not optimistic. At the same time, due to the impact of the financial crisis on Europe and the United States, India, and some emerging economies, the interests of domestic companies will be considered. Restrictions have been placed on Chinese-made pharmaceutical products, and more views have been expressed in favor of trade protection. For example, Paul Krugman, the Nobel Prize winner in economics, published an article in the New York Times, stating that “China’s Mercantilism has caused export surpluses. Harm the interests of the world, and this policy is predatory." The international climate has determined that trade friction will Inevitably, at the same time, the United States and other countries will continue to exert pressure on China in the appreciation of the renminbi, and it does not rule out a new round of currency disputes. The overall trade environment facing China will be very complicated and severe.

The task of upgrading industrial structure is becoming increasingly urgent

In 2008, there were 5,949 enterprises with pharmaceutical sales revenues over 5 million yuan, and accumulated sales revenue was 656.1 billion yuan. The average sales of each enterprise was only 110 million yuan. The total industrial hundred sales revenue was 246.9 billion yuan. Yuan renminbi, the top 100 companies have an overall concentration of 41%, and the top 10 pharmaceutical companies in the world accounted for the proportion of total sales revenue in the global pharmaceutical market from 25% in 1993 to 45% in 2008. The top 10 in the United States Pharmaceutical companies account for 90% of the US's sales. The world's top 10 pharmaceutical companies, their R & D investment accounted for the proportion of sales revenue in the year is generally 15% to 20%, while the proportion of pharmaceutical companies in China is less than 1%, excellent The number of companies rarely exceeds 5%. The low R&D investment and weak innovation capacity have always been the key issues that have plagued the deep-seated development of China's pharmaceutical industry. The majority of companies have a very low R&D investment. At the same time, domestic venture capital markets Has not yet been established, the middle part of the entire technological innovation system has severely broken. At present, the main body of China's pharmaceutical R & D is still research institutes and higher education institutions, most of the companies can not become the master of pharmaceutical R & D Therefore, some key industrialization technologies have not broken through for a long time, which restricts the extension of the industry to high-tech, high-value-added downstream deep-processing products. The product replacement is slow, and it is unable to keep up with and meet the market demand in time. The production, study, trade and trade has severely fragmented. Although the degree of concentration of China's pharmaceutical manufacturing industry has increased rapidly, compared with developed countries, there is still a large gap. The current situation of many enterprises, small and scattered enterprises has restricted the improvement of pharmaceutical innovation capabilities.

In addition, there is also a problem of low concentration in the area of ​​commercial circulation. In 2009, China had a total of 13,000 pharmaceutical wholesale companies, and the total pharmaceutical sales in China was 469.9 billion yuan. The top three wholesalers are Sinopharm, Shanghai Pharmaceuticals, Kyushutong’s sales amounted to approximately RMB 100 billion, accounting for approximately 21% of the total market sales, while the other approximately 1.25% of sales combined together amounted to less than RMB 70 billion, accounting for only 15% of the market share. The average household is approximately 5.6 million yuan. The sales of Cardinal, Mckesson and AmerisourceBurgen, the top three US pharmaceutical wholesalers, accounted for 90% of the total market sales. The market share of the top ten pharmaceutical wholesalers reached 96%. • Too many small businesses in the pharmaceutical business field in China have led to serious disorderly competition, generally low service capacity, unfair competition, and especially the obscure operations tied with the interests of hospitals.

High energy consumption, heavy pollution and waste of resources pose a threat to the sustainable development of the industry

China's pharmaceutical industry is one of the key industries for environmental protection governance. Most chemical raw material drugs have large energy consumption, serious environmental pollution, low added value, three wastes disposal, and increasing pressure for environmental protection. They have leapt to the top in the world in China. Behind the large raw material drug producing countries, the sacrifice of resources and energy has become an incalculable cost. China's annual production of penicillin industrial salt is 60,000 tons, accounting for 90% of the world's production; annual output of vitamin C exceeds 300,000 tons, accounting for world production. 60% of the production capacity of citric acid has reached 700,000 tons, accounting for 65% of the world's total production. Even bulk APIs that are not produced in many poor countries are still undergoing large-scale production in China. The industrial development environment is not due to the value of production. Increasing and improving, but even more serious, the harmonious relationship between man and nature has been unprecedented challenge. In addition, the construction of laws and regulations related to the protection of traditional Chinese medicine resources lags behind, the cultivation and production methods of traditional Chinese medicine are lagging behind, lack of necessary organizations, and do not form a certain The lack of necessary market information in the production and planting process has led to the development and utilization of Chinese herbal medicines in a disorderly state. On the one hand, overexploitation of wild medicinal resources has led to Some varieties are in an endangered situation and are even facing extinction. On the other hand, because of blind planting, a large amount of backlogs are generated, resulting in a huge waste of resources. Many Chinese herbal medicines are exported through primary products in a very low price. As we often use 500 species. Of the Chinese herbal medicines, 112 species must be protected, of which 10 are endangered, 38 are rare, and 46 are in danger. Some Chinese herbal medicines, such as licorice, ephedra, Yinchaihu, Cistanche, Saussurea, Rhodiola, Cordyceps sinensis, Fritillaria Fructus, etc., due to excessive excavation or predatory development, the amount of resources shrinking year by year, has begun to affect the clinical use of Chinese medicine and pharmaceutical companies.

The general lack of internationally certified products and experience in the operation of international markets

After China's accession to the WTO, the boundaries between domestic and foreign markets have become increasingly blurred. There is a multi-game pattern between Chinese and foreign companies. In the process of integration with the international community, China's pharmaceutical companies have three major shortcomings: First, access to the international market, especially to regulate market access. Inadequate capacity. Most of China's chemical raw material medicine products have not obtained the permit to enter the international market. The preparation products passed the cGMP certification of the developed countries such as the United States and Europe. There are fewer than 20 companies. The second is the general lack of international pharmaceutical market operations. Experienced professionals, weak international marketing capabilities, the vast majority of companies only make products, do not market, did not really start their own brands in foreign countries. Third, in the process of dealing with international relations, the handling of intellectual property issues is not To make proper use of it, we often encounter embarrassing situations. Among them, the protection of pharmaceutical intellectual property rights has always been a weak link in the development of pharmaceutical companies in China, and it is also a frequent occurrence area for disputes with foreign companies. China's revised version of the "patent law" implemented on January 1, 1993 In the meantime, patent protection was implemented for pharmaceutical compounds. At the same time, according to the Sino-U.S. Intellectual Property Memorandum signed by China and the United States in 1992, The pharmaceutical inventions patented in more than 40 countries in the United States, the European Union and Japan from the end of 1986 to 1992 provided a retrospective administrative protection as an offset, thereby establishing an important legal system for the protection of intellectual property rights of pharmaceuticals. After China's accession to the WTO, China The protection of intellectual property rights has obviously improved, but there is still a big gap between the requirements and the requirements. Contrary to the protection of foreign patented pharmaceutical products, the pharmaceutical products owned by our country with independent intellectual property rights are not enough. In the State Intellectual Property Office In the “Patent Invention Bulletin”, China’s patent applications for chemical drugs are very few, and most of them are patents for improved processes or dosage forms. Foreign applications account for more than 90%, and most of them are new chemical synthetic drugs; the number of Chinese patent applications is relatively There are many, but the general quality is not high. Even if granted, the scope of protection is very small; although China's patent applications for biological drugs accounted for nearly half, but the inventiveness and quality of the invention is far from that of foreign countries.

On the whole, although the future development path of China's pharmaceutical industry is full of thorns and challenges, the prospects will be brighter. I believe there will be more Chinese pharmaceutical companies starting from their own reality, seize every opportunity as much as possible, and actively Open up, be bold and enterprising, realize the maximization of the company's interests in the international market. At the same time, after the adjustment and restructuring of the Chinese domestic market, it is also expected to achieve a good operational order, release more business opportunities and potential, and become an international pharmaceutical company in particular favored Huge market. China is not far from the world's most powerful pharmaceutical country.