Increasingly clear policy, accelerating the adjustment of pharmaceutical industry structure

On March 24, a joint ministerial meeting closely related to the pharmaceutical industry was held in Beijing It is reported that its content is to specifically discuss how to adjust the structure of the pharmaceutical industry At the same time, a guidance on further accelerating the structural adjustment of the pharmaceutical industry and promoting the healthy development of the industry (Draft for comments), led and drafted by the Ministry of industry and information technology, is circulating in the industry "The next seminar will be held in early April." According to an insider The above signs show that the pace of restructuring of the pharmaceutical industry will be further accelerated with the introduction of relevant policies "The so-called adjustment of industrial structure is the requirement of economic transformation on the macro level and the pursuit of comprehensive benefits such as social and environmental benefits behind the figures." Yu Mingde, President of China Pharmaceutical Enterprise Management Association, said Data shows that from 2005 to 2008, China's pharmaceutical industry's GDP increased by 24% annually, and the total profit increased by 33.8% annually Yu Mingde said that in 2009, China's pharmaceutical industry achieved a GDP of over trillion yuan, an increase of 23% year on year and a profit increase of 26% He predicted that in 2010, the GDP of the pharmaceutical industry will increase by 26% on the basis of 2009, and the profit growth will reach the level of 30% Behind these bright data, however, the deep-seated contradictions and problems of the pharmaceutical industry in China have not been effectively solved For example, there are many, small, scattered and disordered enterprises, low industrial concentration; insufficient R & D investment, weak innovation ability, low proportion of high-tech products, and insufficient sustainable development potential; low-level repetition has not been effectively suppressed, and disordered vicious competition has intensified; there is still a significant gap between the quality management system and international standards, and the quality and safety of drugs are not fully guaranteed; environmental protection in the field of chemical APIs The problems are prominent, and the governance measures are not effective; the domestic market order is chaotic, the survival of the fittest, fair and orderly market order has not yet formed; the pharmaceutical export is mainly low value-added products, and the international market competitiveness is not strong, etc Wei Jigang, deputy researcher of the Industrial Economic Research Department of the development research center of the State Council, said that there are outstanding problems in China's pharmaceutical industry, the first one to bear the brunt is the extensive mode of growth, that is, "high input, high consumption, high pollution and high emissions; low output, low efficiency, low concentration and low scientific and technological content" Statistics from China Chamber of Commerce for import and export of medicine and health care products show that in 2009, China's export of Western medicine was 19.2 billion US dollars, of which the export of raw materials was 16.6 billion US dollars, accounting for 86.45% of the total export of Western medicine products; the export of finished medicine was about 1.2 billion US dollars, accounting for only 6.25% of the total export of Western medicine, despite a year-on-year growth of 7.76%; the export of biochemical medicine was 1.45 billion US dollars, accounting for the whole export of Western medicine 7.55% of the export of Western medicine products Tan Shengcai, director of the Western Medicine Department of the medical insurance chamber of Commerce, told reporters that China's western medicine preparations are not only exported less, but also among the preparations that have already been exported, multinational enterprises have greatly promoted the transfer of preparation production to China In 2009, only 181 foreign-funded enterprises accounted for 14% of the 1299 enterprises with export performance of Western pharmaceutical preparations in China, but the proportion of export volume was as high as 51.92% Similarly, in the field of export of traditional Chinese medicine products in China, both primary Chinese medicine products and secondary primary product plant extracts occupy an absolute share, and the proportion of preparations is very small The export products are mainly primary processing products or secondary primary processing products, which has always been the unbearable weight of China's pharmaceutical industry Yu Guanwen, a senior expert in the industry, has repeatedly lamented that China's API export is "the product goes out, and the pollution is left behind" Ironically, with the increase of API exports, domestic enterprises are also receiving more and more anti-dumping lawsuits from enterprises in other countries In the field of traditional Chinese medicine, researcher Hu Shilin, Institute of traditional Chinese medicine, Chinese Academy of Sciences, wrote many years ago that exporting raw materials of natural drugs is not good, and its damage to wild resources and environment is greater than its benefit Licorice, ephedra and Cordyceps are all bulk export medicinal materials In only a few decades, these resources have become endangered "The most ideal pattern for the export of pharmaceutical products should be the proportion of preparations However, the export of preparations often requires independent intellectual property rights Because of its small scale and poor R & D capability, Chinese enterprises are unable to do so for the time being " On Shengcai The lack of core competitiveness makes the domestic pharmaceutical enterprises not only unable to compete with the international multinational pharmaceutical enterprises, but also at a disadvantage in the fierce competition with India Africa, China's traditional export market, is being squeezed by India, and there is no obvious effect in entering the high-end market "If China's pharmaceutical industry has completed the transformation from small to large in the first 30 years, the task of China's pharmaceutical industry in the next few decades is to achieve large and strong, and the next five years are the key period of transition." Wei Jigang said that the key to changing the development mode is to adjust the industrial structure and improve the ability of technological innovation The pharmaceutical industry needs to realize several changes: from excessive focus on scale growth to structural upgrading, sustainable development and international competitiveness; from only focus on the economic benefits of the pharmaceutical industry to focus on economic benefits, ecological benefits, social benefits and environmental benefits; from extensive development to intensive development, that is, from high input and low output to scientific and technological innovation, management innovation The improvement of the quality of workers, the improvement of labor factors and so on He suggested that, while traditional industries are mainly upgrading their products, they should actively develop new products and rush to imitate the patent drugs that are about to expire in the world The state should also focus on the biopharmaceutical industry and deploy the drugs needed by the people for major diseases Yu Mingde's view coincides with Wei Jigang's According to Yu Mingde, the adjustment of pharmaceutical industry structure is mainly manifested in two aspects: first, the upgrading of traditional pharmaceutical industry The so-called upgrading mainly refers to the upgrading of traditional technology, equipment, standards, environmental protection, etc Secondly, we should focus on emerging industries and occupy the commanding height of biomedicine "Specifically, for the traditional medicine industry, we mainly focus on process improvement For example, reduce the previous six step reaction to three-step reaction Although the product is still produced, the method and path are different The pollution emission is less and the quality standard is improved " Yu Mingde said that modern biopharmaceuticals refer to the use of four major engineering technologies for drug production, including gene engineering, cell engineering, genetic engineering and enzyme engineering Although China's biopharmaceutical industry started late, the gap with the world's leading level is not too large, and the growth rate is very fast, which has laid a good foundation for the development of China's biopharmaceutical industry In the process of drafting the 12th Five Year Plan, biomedicine has been listed as a strategic emerging industry "Monoclonal technology has been greatly developed in China, and it is in urgent need of product pilot scale up and industrialization Monoclonal antibody and vaccine are two kinds of biotechnology, which will become the commanding point of life science in China " Yu Mingde said Talking about Shengcai also said that in terms of exports, China's pharmaceutical industry cannot lose the basic advantages of APIs The so-called industrial upgrading means, on the one hand, encouraging the production of high-end APIs, accelerating the certification of international high-end markets, and increasing the proportion of characteristic APIs in high-end markets; on the other hand, accelerating the research and development of preparations, in addition to scrambling for imitations, striving for breakthroughs in biopharmaceutics, with a view to the emergence of patent varieties It should be said that some forward-looking enterprises in China have begun their industrial upgrading efforts On June 26, 2007, Huahai Pharmaceutical Co., Ltd obtained the first pass of FDA certification for domestic preparations At the end of November 2008, 900000 fluvastatin capsules of Haizheng pharmaceutical were officially packed and shipped to Europe, marking the official export of Haizheng's own brand preparations After that, Haizheng pharmaceutical industry focused on the field of biopharmaceutical In addition, with the overall relocation of large pharmaceutical groups, leading domestic enterprises such as Sinopharm, Sinopharm, Harbin pharmaceutical, and Dongyao have all taken the opportunity to upgrade their industrial structure and adjust their product structure Taking Chinese medicine as an example, the traditional penicillin production is no longer its focus In the planning of its industrial park, high-tech drugs such as genetic engineering drugs, anti-tumor drugs, antiviral drugs, etc will account for the main share of its future sales It is undeniable that policy incentives are gradually in place, and it is far from enough to rely on the efforts of enterprises themselves "For the technological transformation of traditional industries, all the government has to do is to guide and create a good environment for the adjustment of industrial structure." Yu Mingde suggested that for energy-saving projects, the government could provide financial support such as interest free loans; for enterprises to build pollution projects, the government could refund a certain proportion after collecting pollution fees "China has improved GMP standards, and it is possible to implement cGMP in the future For those enterprises that take the initiative to do so, the government must give certain policy support; for those enterprises that do not, the government should also think of some ways to stimulate enterprises to do so " Yu Mingde said It is reported that the national development and Reform Commission is discussing some stimulating policies related to the structural adjustment of the pharmaceutical industry In addition to the special project of modernization of traditional Chinese medicine, the special project of upgrading the quality of drugs will be launched soon In this special project, we should not only support the enterprises whose preparations have entered the mainstream market in Europe and the United States, but also support those enterprises that have not passed the EU cos, the U.S FDA certification, etc., but actively strive for this, so as to encourage enterprises to improve quality standards and encourage products to go to the world The national development and Reform Commission also plans to carry out a unified plan for generic generic drug imitation and the scramble for generic drugs that are about to expire, relevant people also said The reporter also found that "a number of patents with good curative effect, large market demand and high technical complexity are to be deployed in advance, and the R & D and industrialization of characteristic APIs are to be included in the industrial structure of the Ministry of industry and information technology", "strengthening the development of famous doctors and famous prescriptions, the secondary development of famous and excellent Chinese patent medicines (including ethnic medicines), and accelerating the modern R & D and industrialization of traditional pharmaceutical products" are to be included in the industrial structure of the Ministry of industry and information technology Adjust your goals Not only that, in the goal of technology structure adjustment, MIIT will focus on "solving a number of key process technologies that restrict the development of China's pharmaceutical industry to the field of high technology and high added value downstream deep processing products, as well as common technologies such as green and clean production, pollution control, and circular economy We will implement and promote a number of energy-saving and environmental protection technologies in the pharmaceutical industry It is reported that the Ministry of industry and information technology will also speed up the development and update of the catalogue of industrial restructuring, focusing on chemical APIs, further develop and improve energy conservation and environmental protection standards, strengthen the approval and credit management of new and expansion projects, strengthen the comprehensive environmental assessment, and strictly limit the blind expansion of production capacity of some large varieties of APIs Talking about Shengcai told reporters that the medical insurance chamber of commerce is also negotiating with relevant departments, hoping to give preference to pharmaceutical export enterprises in terms of policies, such as increasing the rebate rate of pharmaceutical products from the current 15% to 17%, improving the pricing of products certified in the high-end market, providing enterprises with some subsidies for hardware investment after the implementation of quality standards in the high-end market, and pharmaceutical products for enterprises to foreign markets Help with registration and promotion.