With modern and comprehensive perspective on Chinese medicine and its industry

Time: 2015-11-17

Source: China economic times

Author: Lv Gongxing

Tu because of artemisinin and won the Nobel Prize, once again led to traditional Chinese medicine scientific debate. To this, the state council development research center, information center at long Li Guangqian, "says Dr. Tu awards will bring both sides to traditional Chinese medicine (TCM) : the influence of positive impact is that it will brings to the culture of Chinese medicine in the world within the scope of the revival of a rare historical opportunity, speed up and promote the internationalization of Chinese medicine; Negative impact is that someone tu's award as a typical case of Chinese traditional medicine western medicine, and vigorously to denigrate the science of TCM.

Li Guangqian to the China economic times reporter said, we should be scientific and rational, comprehensive understanding modern property of traditional Chinese medicine (TCM) system. Don't think Chinese medicine can be to simmer, stew, decoct, boil, the active ingredients were extracted with modern science and technology for development is western medicine, can't take Chinese traditional medicine and modern science and technology are completely opposite. Western medicine, he thought, the progress is from the progress of modern science and technology of western medicine, Chinese medicine also can use modern technology to its intrinsic properties "present".

Traditional Chinese medicine (TCM) has a multidimensional attribute modernity

China economic times: tu the won the Nobel Prize in physiology or medicine, some people think that is the result of the "traditional Chinese medicine (TCM) modernization". Moreover, since the 1990 s, modernization of traditional Chinese medicine, became a national development direction of Chinese medicine industry. But in theoretical circle, especially in medicine, but to the modernization of traditional Chinese medicine (TCM) has a different view. How do you understand the modernization of traditional Chinese medicine?

Li Guangqian: to understand the core of traditional Chinese medicine (TCM) modernization, is the modern attributes to in-depth analysis of traditional Chinese medicine, we can call it Chinese medicine modernity. Concepts and ideas in the field of modernity, modernity in Chinese traditional medicine should refer to those properties of Chinese traditional medicine era characteristics. These properties also should be multidimensional, including medical, technical, industrial session, culture, public management properties, and so on five aspects.

Medicine, suggests that as a drug, traditional Chinese medicine (TCM) must be separated with food. Although traditional notions of "medicine food homology", but in modern times, traditional Chinese medicine (TCM) as a drug properties will increasingly rather than as food value. Medicine is the primary factor of traditional Chinese medicine (TCM) modernity. If lack of curative effect, the so-called traditional Chinese medicine (TCM) there would be no value.

Technical means of Chinese herbal medicine planting, processing, proprietary Chinese medicine production, save, and even use needs to be continually used the advanced science and technology, and through the formation of the corresponding technical standards. Here, the technical points of external and internal technical technical. We can be a professional area own industry knowledge and professional skills as the internal technical. Therefore, the "technical" actually refers to the external technical, and medical internal technical can be regarded as traditional Chinese medicine. Apply modern science and technology (external technical) is not only the requirements of the development of Chinese medicine, is also used to improve the traditional Chinese medicine pharmaceutical (technical) within the important condition.

Industrial session, refers to as the development of society and economy, the traditional Chinese medicine industry is not only a clear division of responsibilities of each link, the competition is intense, and each other because of the value creation and more closely relates in together, become a huge industry chain, become a strong driving force to promote the development of traditional Chinese medicine industry. Industrial session in promoting Chinese medicine career development is increasingly play a decisive role. To reform, rationalize, and promote the new drug development and industrialization of hospital preparations formation mechanism, and through every link of the role of the capital market to accelerate the production scale and standard, to promote the healthy and rapid development of the undertaking of traditional Chinese medicine (TCM).

Culture refers to the long-term development, Chinese medicine has been linked with Chinese philosophy, culture, history, traditional Chinese medicine constitutes an important part of Chinese culture and traditional knowledge. Culture is different from other countries of traditional Chinese medicine herbs, herbal medicine, the important factors that have important value to the development of Chinese medicine in the future.

Attribute of public management, due to drugs to people's health and life safety closely linked, so the society increasingly strict management of the drug, especially due to the development of market economy and the establishment of the social security system, drug and corresponding all kinds of system construction and public management system together. Attribute of public management is playing a more and more important role on the development of TCM, if Chinese medicine is not corresponding innovation according to the needs of the development of modern society, it will be increasingly marginalized, and public management attributes directly decides the survival and development of Chinese traditional medicine.

Traditional Chinese medicine (TCM) contains three path innovation development

China economic times: for any industry, innovation is an important factor of its continued development. For traditional Chinese medicine industry, the innovation and development have a certain path?

Li Guangqian: in fact, the innovation and development of traditional Chinese medicine not only can produce similar Yu Qinghao element with a single chemical composition of the drug, also can produce similar to the chemical composition of compound danshen dropping pill complex components of traditional Chinese medicine, of course also have very traditional varieties and their corresponding dosage forms of traditional Chinese medicine. And traditional Chinese medicine (TCM) innovation and development also contains three path: the path to a direction for the development of similar to western medicine, path were still supported by theory of traditional Chinese medicine new medicine, 3 it is to adapt to the new path signs or with a new curative effect of traditional Chinese medicine. At the same time, we can also see path three as inheritance, innovation, and the paths one or two as the development of innovation.

In both "inheritance innovation" and in "the development innovation", should be accompanied by appropriate protective measures. These measures in addition to including patents, trademarks and other intellectual property protection, also should be fully applied to protection of TCM variety of comprehensive protection measures. Especially the protection of TCM variety, is currently in addition to patent protection on the innovative way of development and protection of Chinese medicine, traditional Chinese medicine can give enterprise to provide more sufficient incentives for innovation.

To active protection is the trend

China economic times: since when it comes to protection of TCM variety, wouldn't that take effect on January 1, 1993 of the regulations on the protection of TCM variety (hereinafter referred to as the regulations), some experts believe has 22 years, the regulations should be revised. You recognize this view? How do you think should be revised approval?

Li Guangqian: the implementation of the regulations that the chaos of the Chinese medicine market in China has been effectively controlled, made a number of old enterprises under the market environment of stable life, such as Beijing tongrentang, LeiYun classy, emerge a number of sales in more than 1 billion yuan a single Chinese medicine varieties, such as compound danshen dropping pill, jianwei xiaoshi tablets. But with the development of the situation, already can't meet the needs of current, the regulations need to be revised. Specific should include the following aspects:

First, from the passive protection to active protection. Current protection, is to apply for protection by the enterprise first, and then by the mediator do organize experts to review and make a conclusion whether enterprise protection. In this case, the state food and drug supervision and administration bureau for the protection of which variety and actually not much initiative which technology, in the same variety protection, the situation is especially obvious. We can be this kind of situation is called passive protection.

Ways of protection of traditional Chinese medicine should be in the future on the basis of perfecting the existing way of protection increases initiative: the relevant government departments, after careful study and investigation, make active protection principles and conditions, and on the basis of the selected range of varieties of traditional Chinese medicines to protect, and need to be protected enterprise work content; By introducing the auction after the way, let the competitiveness of the enterprise through a certain process to protect rights of TCM products. This mechanism can be used to complete the innovation of traditional Chinese medicine (TCM) modernity just drug resistance, and other technical need to complete tasks.

Second, from the purely administrative protection to introduce market competition mechanism. From a legal point of view, the current is considered to lack of fairness, the regulations of some enterprise is given only to the protection of the rights to deprive other enterprise the legitimate rights of pharmaceutical production. This is one of the most criticized by person place the regulations. However, if by passive protection to active protection, on the program to introduce market competition mechanism, can overcome the fairness problem. In fact, the administrative protection has no fault, the key is to be able to adhere to the principle of "openness, fairness and justice". The whole process is similar to the government purchasing public service usually.

Third, by proprietary Chinese medicine manufacturing link protection to proprietary Chinese medicine industry chain upstream and downstream protection. In addition to existing rules to protect the the regulations, should also be based on the actual needs of Chinese medicine development innovation, will be more relevant content into the protection scope.

The regulations in the future should be to breed protection for the fulcrum, expand the territory, with an eye to the whole industry chain of traditional Chinese medicine, promote forward scale, standardization of Chinese herbal medicine planting, processing, and pay attention to the taste and quality, quality of medicinal materials; Back to promote science and rationality of production technology, advanced machinery and equipment, production and management of high efficiency, etc., focus on industry technology innovation and development and modernization, promote the traditional Chinese medicine (TCM) technical requirement and the level of modernity.

In this sense, the future of traditional Chinese medicine varieties protection system should be to make the transition to TCM protection system.

Fourth, the varieties of traditional Chinese medicines by simple protection to the inheritance, innovation of Chinese traditional medicine. Issued by the state food and drug supervision and management of administration in 2009 of the protection of TCM variety guiding principles in promoting innovation and development of Chinese medicine theory, towards the kbe increased a lot in the process of review of technical requirements, such as requiring approval pre-market research must include information of pharmacology and toxicology and clinical, pharmacy, pharmaceutical data including process, quality standard data; Approval of research materials must include the adverse drug reactions monitoring information related to the implementation and quality standards. However, since these is still under the condition of passive protection, thus these policies to promote the innovation and development of traditional Chinese medicine is still difficult to get fully play.

Fifth, by a single (or several) of enterprise protection to the varieties of industry transformation. On the actual effect of it, is, in fact, the regulations on protection of a single enterprise (exclusive varieties), or a number of companies (with varieties, market monopoly or fault management rights. And for those who although has obtained the approval number varieties but didn't get the same variety protection of enterprise, obviously is not fair, but also harm the authority of the pharmaceutical administration law and its drug approval number and seriousness.

Internal cause is still the main factors of the international market penetration

China economic times: data show that in the international market, from the 1980 s, the comparative advantage of TCM industry of our country decline. In 2014, the export of artesunate preparation only account for 8% of the formulation of international market share to 10%. Do you think of the current Chinese proprietary Chinese medicine in the international market share low what are the reasons?

Li Guangqian: first of all, the reason is still the main internal factors, embodied in the following four aspects:

First, China's traditional Chinese medicine (TCM) field for a patent for invention without apparent increase. According to the state intellectual property office of the statistical data from 1985 to now, 20 years, China's traditional Chinese medicine (TCM) always did not see obvious increase of the number of applications for a patent for invention, hovering at 1700 items. In contrast with the domestic, Japan, Korea, Germany and other foreign companies for traditional Chinese medicine patent applications is growing. Some multinational pharmaceutical companies use cooperation ceaselessly, mergers and acquisitions, mergers and acquisitions in China some valuable viewpoints, prescription medicine field. It is understood that in the United States patent application in Chinese medicine, Japan has accounted for almost half, and few in China.

Second, the Chinese medicine market order and regulation of market at home and abroad is not standard. TCM products quality good and bad are intermingled, many Chinese medicine without brand, with brand of traditional Chinese medicine (TCM) suffered from counterfeit, fake and inferior products with domestic and international market, Chinese medicine is often read gone mouldy events; Heavy metal content, pesticide residues is the direct factors affecting the quality of export of proprietary Chinese medicine, and export quality requirements of traditional Chinese medicine, to fake drugs and substandard products bring opportunity to fish in troubled waters.

Third, the Chinese native medicine ingredient effect is difficult to define like western medicine science. Traditional Chinese medicine at present mainly in health food products, natural health products and food additives, and other forms to enter the international market, don't tell the function, the attending; And for the public to buy the suit, the guidance of professional, easy generation drugs poisoning a large amount for a long time, have a negative impact.

Fourth, the competitiveness of Chinese medicine products export enterprise is weaker. At present, China's traditional Chinese medicine production enterprises is the basic condition of small scale, low efficiency, backward production equipment, products of a single, repetitive production seriously. The data show. More than 80% to more than 1200 Chinese medicine pharmaceutical enterprises in China belong to small and medium enterprises. 95% of enterprise products market share is less than 1% of total sales, even there are nearly hundred the backward situation in traditional Chinese medicine factory production of a drug. Enterprise in extraction, shape, etc. The technology is still have a few decades ago, few adopts high-tech achievements.

Second, external rejection and restricting is the important factor, is embodied in the following three aspects:

First, the differences between Chinese and western culture restricts the internationalization of Chinese medicine. Due to the cultural differences between east and west, the west with strong Chinese traditional cultural background of traditional Chinese medicine is poorly understood. And international don't understand the difference between the traditional Chinese medicine and herbal medicine, do not understand the difference between the traditional Chinese medicine and western medicine, so difficult to understand traditional Chinese medicine in a short time. At the same time, the high quality of research papers published in international journals of Chinese medicine is less, make the person of Chinese medicine scientific questions.

Second, the western developed countries themselves reject traditional Chinese medicine (TCM). By the stubborn self-righteous rejection, the power of western medicine, thought is far lower than the modern medicine and traditional medicine that cannot be incorporated into the social security system of traditional Chinese medicine. In addition, the Chinese medicine personnel lack of organization, cannot unite dialogue with the local government, to communicate effectively.

Third, the policies and regulations to be exporters understand enough. Such as Australia rules the first condition of foreign drug company exported products to Australia is GMP certification, to obtain TGA and domestic pharmaceutical companies lack of enough understanding Australia GMP standard.

Multi-pronged improved competitiveness

China economic times: internationalization of traditional Chinese medicine and its industry, what are your Suggestions?

Li Guangqian: first, to strengthen the publicity of Chinese medicine. Abroad, especially the use of the Confucius institute to develop formal education of Chinese medicine, Chinese traditional culture, cultivate talents of Chinese medicine, improve the overall level of Chinese medicine; On the other hand, to attract more foreign students to China to study Chinese medicine, and abroad to establish a demonstration hospital, vigorously promote the curative effect of TCM. Currently, especially need to vigorously promote TCM theory for tu discovered artemisinin important guiding significance and value, improve the notion of traditional Chinese medicine in the international pharmaceutical industry.

Second, seize the opportunities of globalization, promote the internationalization of Chinese medicine. First of all, for traditional Chinese medicine internationalization of economic globalization brings opportunities. Multinational companies to become the important carrier of economic globalization, global industrial transfer, including the pharmaceutical industry, the internationalization of traditional Chinese medicine (TCM) provides an important opportunity. Second, the return nature provide opportunities for internationalization of Chinese traditional medicine. Seek a green economy in recent years, many developed economies, return to nature, more use of plant medicine, internationalization has brought another important opportunity for traditional Chinese medicine.

Third, to strengthen communication, communication, cooperation between the government, accelerate the internationalization of Chinese medicine. One is the use of international organizations, promote the internationalization of Chinese medicine. Second, strengthen negotiation between countries, maintenance of the international legal status of Chinese traditional medicine. Third, in the bilateral and regional agreements, provide conditions for traditional Chinese medicine internationalization, as far as possible to the internationalization of Chinese medicine into the national strategy of "area". Four is to strengthen international scientific research cooperation, deepen understanding of traditional Chinese medicine and to use.

Fourth, encourage, support and training with the international competitiveness of Chinese medicine in a multinational company. Content mainly includes three aspects: insist on innovation development path, bigger and stronger enterprise brand of traditional Chinese medicines; Encourage and support Chinese medicine enterprises of foreign investment, to speed up the pace of Chinese medicine into the large foreign pharmaceutical market; Through the merger and reorganization to foster Chinese medicine multinational companies.