Difficulties in internationalization of traditional Chinese Medicine

The UK drug administration plans to ban the sale of unregistered Chinese patent medicines in the UK from the beginning of next year At present, only one enterprise in our country has passed the registration of drugs At the same time, relevant departments in Canada and other countries have also warned about the safety of traditional Chinese medicine In this context, part of the plant extracts exported by China are produced as "foreign traditional Chinese medicine" and sold back to China at a high price The road of internationalization of traditional Chinese medicine faces many challenges At the weekend of rule of law, Cai Changchun, a reporter from the UK Drug Administration (hereinafter referred to as "the UK drug administration") recently showed a red card to the Chinese patent medicines sold in its territory It is reported that the UK drug administration has informed the TCM societies and some large TCM stores to report the quantity of their own stocks of Chinese patent medicines, and plans to ban the sale of unregistered Chinese patent medicines in the UK from the beginning of next year For a while, the news that Britain has "banned" Chinese traditional medicine products spread widely According to Liu Zhanglin, vice president of the chamber of Commerce for the import and export of health care products of China Pharmaceutical (600056, Guba), this is just a continuation of the UK's implementation of the EU's 2004 directive on the registration procedure of traditional plant drugs (the directive is called the 2004 / 24ec directive by insiders), and it is not an emergency The Directive requires that, after May 1, 2011, unregistered Chinese patent medicines shall not be sold as medicines in the EU market "However, among the domestic traditional Chinese medicine enterprises, only one company, Chengdu Di'ao, has passed the registration so far, and other companies are still in the process of applying for registration or considering registration." Liu Zhanglin also said frankly In this context, Zhang Wensheng, a senior person in the pharmaceutical industry and a lawyer of Beijing Jinghan law firm, told the reporter of rule of law weekend that a large part of Chinese medicine products exported by China are plant extracts, which are often processed into "foreign Chinese medicine" and sold back to China at a high price In this situation of "internal and external troubles", how to improve their own quality to achieve better internationalization has become a big problem in front of the domestic traditional Chinese medicine industry Liu said it was no surprise that the registration behind the ban was difficult to make a statement to the UK drug administration Liu told rule of law weekend that this is due to historical reasons, because the sales of Chinese patent medicines in the UK have always been in a gray area "Some Chinese patent medicines have entered the UK market as medicines without being registered." Liu said According to Liu Zhanglin, according to the directive on the registration procedure of traditional botanical drugs issued in 2004, all traditional Chinese medicines sold in the EU market must go through quarantine registration after a 7-year transition period, before they can be sold as medicines However, on April 30, 2011, there were still some stocks of Chinese patent medicines in the UK market, and relevant departments promised to allow this Some stock goes on sale "Even so, there will be a deadline for the sales process Now the UK drug administration has announced a comprehensive ban on the sale of unregistered Chinese patent medicines in the UK, which is only a normal action taken in strict accordance with the law " Liu said However, why has only one Chinese company registered its products in the UK for so many years? Liu Zhanglin roughed up the cost of registration of a Chinese patent medicine in the European Union to reporters at the rule of law weekend: it would cost at least 45 million yuan to register a drug Because the registration fee equivalent to 1 million yuan will be paid for the submitted materials; in addition, the application for registration must meet the recognition standard of the European GMP The requirements of the European Union are almost the most stringent in the world The production workshop and equipment of the enterprise need to be modified, even if the hardware equipment of the enterprise has been relatively good, due to the relationship between the software and other management levels There are few notes It will cost at least 34 million yuan to reconstruct the original management system "If a company wants to register more than one product in the EU, the cost can be imagined." Liu Zhanglin said However, Liu Zhanglin told rule of law weekend that according to the statement given by the UK drug administration, all unregistered Chinese patent medicines will no longer be able to enter the market, but this does not mean that the "total ban" of traditional Chinese medicine "What is banned in the UK is only Chinese patent medicine, and other commodities, including herbal pieces or plant extracts, as well as formula granules and one-to-one TCM hospital treatment, have not been affected." Liu Zhanglin introduced According to the reporter at the weekend of rule of law, at present, the EU is one of the world's largest vegetable drug markets, and also an important target for the export of Chinese traditional medicine products According to the data, at present, the export volume of Chinese patent medicines in China is up to 200 million US dollars per year, of which the EU market only accounts for less than 20 million US dollars, with a small market share In recent years, the UK has been reducing the size of its traditional Chinese medicine market In 2012, China exported $1.62 million of Chinese patent medicines to the UK, down 69.81% year on year But Zhao Zhen (pseudonym), a senior medical marketer, told the rule of law weekend: "given the importance of the UK in the current EU market, it has set a precedent, and its behavior is likely to be imitated by other countries, which will also have a negative impact on the export of domestic traditional Chinese medicine enterprises." In fact, prior to the "remediation action", the UK Drug Administration issued a warning in August this year, reminding consumers to carefully select some traditional Chinese medicines that have not been officially registered in the UK, saying they contain high levels of harmful toxins, including lead, mercury and arsenic At the beginning of this year, the Health Ministry of Canada also issued a circular warning to the public not to buy or take a number of Chinese patent medicines containing heavy metals such as excessive mercury and lead, including Tianma headache pill, Dendrobium night light pill and other products In the future, the overseas sales pressure of Chinese patent medicine can be imagined Why the export of traditional Chinese medicine has been blocked many times has become a common phenomenon in the industry So, as one of the treasures of Chinese medicine, why does Chinese medicine suffer many setbacks on the road of internationalization? Previously, some industry insiders pointed out that some countries have repeatedly put pressure on China's export of traditional Chinese medicine products, and there is suspicion of deliberately adding trade barriers Zhang Wensheng said that this possibility cannot be ruled out, but it is not the main reason for the blocked export of traditional Chinese medicine Liu Zhanglin also said in an interview with the rule of law Weekend reporter that China had held consultations with the EU on this issue at the WTO level in 2010, but the response of the EU has always been: "this registration and sales regulations are not considered as trade barriers, and traditional Chinese medicine is welcome to enter the EU market." So why are the obstacles still there? Duan Jinsheng, a senior Chinese medicine expert, believes that the root cause lies in the incompatibility of the theoretical system of traditional Chinese and Western medicine In Duan Jinsheng's view, traditional Chinese medicine is a drug applied under the guidance of traditional Chinese medicine theory, which is based on experience and fuzzy; western medicine theory is based on empirical science, which is generally clear Duan Jinsheng told the reporters at the rule of law weekend that although the theoretical and practical exploration of modern Chinese medicine modernization has never stopped, it has not achieved a systematic breakthrough so far "Therefore, traditional Chinese medicine with fuzzy theory, fuzzy standard, fuzzy efficacy, fuzzy content and fuzzy side effects is always difficult to be accepted by foreign countries." Duan Jinsheng thinks Duan Jinsheng has been engaged in the sales and inspection of traditional Chinese medicine in some European countries In his practical work, he found that western medicine would consider more about the effect of a single product and think that it may have some toxic side effects; while traditional Chinese medicine pays attention to "attacking poisons with poisons and treating them dialectically", which is a kind of cognitive conflict in itself Zhang Wensheng also told rule of law Weekend reporter that western medicine should be accurate to single drug ingredients Traditional Chinese medicine often appears in the form of mixture In most cases, it is difficult to distinguish the ingredients in traditional Chinese medicine "The state of this mixture often creates significant uncertainty in the regulation of safety." Zhang Wensheng said that because western countries do not have such a long history of using traditional Chinese medicine as China, it is also difficult to accept it in a short time Yuan Kelun, manager of the International Trade Department of Guangzhou Qixing, told the reporter at the rule of law weekend that the EU requires that the application materials such as pharmaceutical test results, product characteristics summary, etc should be submitted for registration of traditional Chinese medicine, and the ingredients of each Chinese patent medicine should be provided In addition, the EU also requires the submission of pharmaceutical tests including heavy metal tests, content determination of markers or active ingredients, stability tests and genotoxicity tests "However, due to the serious shortage of traditional Chinese medicine in modern pharmacy, pharmacology and toxicology research, we can not get information such as which component of a drug plays a major role For example, if we want to register Liuwei Dihuang Pill in the European Union, we need to provide in detail which ingredients are contained in Liuwei Dihuang pill, and which proportion of each ingredient is stable in the process from feeding to production, but this is the short board of traditional Chinese medicine research " Yuan said "In addition, Europe has very strict requirements on the planting environment, extraction process and other aspects of traditional Chinese medicine plants, with a very meticulous food and drug management law." Duan Jinsheng believes that the current test methods and test data of traditional Chinese medicine are still largely unrecognized by the other side In Zhang Wensheng's view, traditional Chinese medicine in many western countries' health undertakings, it is difficult to get its attention in China, or even in a dispensable state, which also increases the difficulty of entering the international market of traditional Chinese medicine "The problems of heavy metals and pesticide residues cannot be ignored." Zhang Wensheng believes that this is also a big problem that needs to be solved when traditional Chinese medicine enters the international market The game with "foreign traditional Chinese medicine" is very difficult in the internationalization of traditional Chinese medicine At the same time, a trend of "foreign traditional Chinese medicine" back to China is quietly rising According to the statistics of China Chamber of Commerce for the import and export of medical and health products, the export of plant extracts in the first quarter of 2013 amounted to US $330 million, accounting for 47% of the export of traditional Chinese medicine It is reported that these plant extracts exported by China have been processed into higher value-added "foreign traditional Chinese medicine" or health care products, cosmetics, etc., many of which have been returned to China Liu Zhanglin told rule of law weekend that after entering the international market, China's plant extracts are mainly provided to local people as plant medicine or dietary supplements, most of which are directly exported to the international market for direct consumption Liu Zhanglin also said that plant extracts like ginkgo biloba have also been transferred back to domestic sales, but the proportion is relatively small But Zhang Wensheng believes that "foreign traditional Chinese medicine" has actually become a trend "Chinese traditional medicine enterprises in China are equivalent to providing a raw material (plant extract) Foreign pharmaceutical enterprises refine the raw material into monomer according to its specific efficacy, which is equivalent to a western medicine." Zhang Wensheng said According to Zhang Wensheng, this "foreign traditional Chinese medicine" mode is relatively popular in France and Germany After the products are formed, Chinese enterprises will introduce them into China as imported drugs It is said that every year Germany comes from China