On September 8 and 9, the 2010 International (Bozhou) Traditional Chinese Medicine (TCM) Expo themed “Healthy/Development/Innovation/ Win-win” was held in the Bozhou Convention Center in Anhui Province. The expo attracted more than 400 medical enterprises. On September 12, the first National Forum on TCM Development was held in Guangzhou province. Wang Guoqiang, vice minister of the Ministry of Health and Commissioner of the State Administration of TCM, expressed that “As a National Forum on TCM Development (Pearl Forum), it should highlight the principle of ‘strong conception, high level and keen insight,’ and it should be dedicated to promoting the comprehensive, coordinative and sustainable development of China’s TCM cause.” It is not hard to see from such conferences that China has paid more attention to the development of TCM.

 

In recent years, a number o f international pharmaceutical giants have entered the Chinese market. They have earned huge sums of money, and attracted the close attention of China’s media. Their success is not only featured with the economic driving force of enterprises, but also their medicine patents. It has been reported that among the medicines produced by Chinese pharmaceutical enterprises, imitation medicines account for more than 95%. Comparatively, new medicines account all but a few.

 

 

Fortunately, the Chinese government has long been aware of the importance of innovation wi thin the medica l industry. The related departments have enacted a number of policies to maintain pharmaceutical advancement; particularly, the unprecedented support for TCM development. In 2006, China enacted the National Outlines for Medium and Long-term Planning for Scientific and Technological Development (2006-2010) (hereinafter referred to as DevelopmentOut l ine ) , requi r ing focus on the theoretical innovation and research of the traditional Chinese medicine industry. In 2007, the Outline of the Plan for the Innovation and Development of Traditional Chinese Medicine (hereinafter referred to as Innovation and Development Outline ) was required to establish a TCM criteria/standard system. In 2009, Some Opinions of the State Council on Supporting and Promoting the Development of the Traditional Chinese Medicine Industry (hereinafter referred to as Opinions ) detailed specific measures on the development of TCM.

 

The Opinions issued in 2009 particularly emphasized the importance of innovation on TCM development. It further required the establishment of a scientific and technological innovation system, evaluation system and management system; reforming and innovating project management model; integrating TCM scientific and technological resources and supporting the innovative development of TCM. These measures have illustrated that support for TCM had been drawn from a framework of large proportion.

 

Sang Guowei, vice chairman of the Standing Committee of the National People’s Congress, stated during the Third TCM Industry Development Conference that the World Health Organization issued a notice saying that the traditional medicine, especially the traditional Chinese medicine, maintained a widespread use in developing countries and the use in industrialized countries also showed a rapid increasing tendency. Nine varieties of traditional Chinese medicine have been collected in French pharmacopoeia. The use of TCM in Germany is so common that it has obtained wide recognition. 90% of all Germans have used traditional medicine, and 70% of the Canadians once tried traditional Chinese medicines. In America, the related number is about 158 million.

 

Overseas Chinese may account for a major percentage in the above-mentioned data. However, whether traditional Chinese medicine flourishes, vitally depends on TCM innovation and its distinctive effect. It has been reported that most present TCM originates from ancient TCM. When taken to the realm of new medicines, TCM finds no position. Of course, such a situation is inseparable from insufficient research anddevelopment.

 

 

Although China has carried out various preferential policies for the development of TCM, the existing problems have become its bottleneck. With economic globalization , technological progress, and rapid development of modern medicine, the characteristics and advantages of traditional Chinese medicine have gradually faded out. Older TCM experts have found no means to convey their academic ideas and experiences; some diagnosis and treatment techniques and methods are on the verge of extinction; TCM theories and technical methods lack innovation; and TCM development has lost balance as natural TCM resources have been severely damaged. These facts have become the “stumbling block” for TCM’s further development. Additionally, Hen Kaixian, academician of the Shanghai Traditional Chinese Medicine University, believes that TCM is the material basis for preventing and curing diseases. To satisfy the demand of society and conform to the development trend of TCM, it is necessary to explore and clarify the essence of TCM theory (TCM material basis, mechanism and compatibility rules) and its scientific connotation to promote TCM’s safety, quality and controlling standards and push forward TCM internationalization. Meanwhile, he also pointed out that after years’ development the modernization of TCM has achieved important progress. However, there are still some problems

to be solved, for example, compared with rich technical applications, theoretical, and methodological research always proves inadequate enough; single disciplinary research accounts for a large part while interdisciplinary research is insufficient; the interpretation of TCM theory accounts much more than creative innovation and institutions scattered without a complete study system.

 

Regarding the bottlenecks in the development of TCM, Zhang Boli, academician of the Tianjin Traditional Chinese Medicine University, also points out that the main restricting factors in the development of Chinese medicine include: first, the traditional techniques and methods of diagnosis and treatment have not been properly inherited, a lot of clinical experience has not been fully digested and the traditional processing methods have not improved; second, thefoundation of modern science is weak as there is little communication between TCM theories and modern science and technology; third, the evaluation standards are not yet complete and the treatment

techniques have not represented a systematic, standard and objective; fourth, the advantages and characteristics of TCM in the prevention and treatment of serious diseases are not highlighted; and fifth, there is a lack of outstanding highlevel TCM professionals.

 

When talking about TCM development, whether he is an entrepreneur or a scholar, he will mention the blockage of an overall innovation capability. Although TCM originates in China, the TCM research in China is still rather weak. China’s annual drug use per capita is only one-tenth of the few developed countries, 95% of medical varieties produced by China’s pharmaceutical industry are imitation medicines of foreign varieties, and China’s TCM exports account for less

than one-tenth of the international herbal medicine market.

 

In addition, the intellectual property issue involved with TCM’s entrance to the market should not be ignored. IPR protection related with TCM covers a large range, including TCM crude materials, prescriptions, extracts, preparations, pharmaceutical engineering, related products, literature, and information resources. The related protection institutes vary with the protected objects, including patents, trademarks, copyrights, trade secrets, plant varieties, executive protection, and border protection. Each institute has its own areas of protection and institutional advantages.

 

Recent reports indicate that at present, many domestic TCM enter prises adopt a two-pronged protection approach, that is, trade secret protection and patent protection. Both are targeted at the protection of technology. Due to the special nature of TCM R&D, patents can only be limited to its prescription. However, when the medicines reach the market, existing technology cannot quarantine its specific components. Therefore, when enter prises find their legal rights being infringed, they find no means to sustain the rights. Obtaining evidence is most difficult. On the contrary, the detection of the components of western medicines is very clear. Therefore, enterprises believe that patent protection alone cannot fully protect TCM.

 

TCM protection also involves the shift of proof burden. China IP consulted Qu Weijun, deputy general manager of CNKnowHow Intellectual Property Agent Limited. She illustrated the principle as follows: If you thought another company infringed upon your legal rights, as long as you owned the basic reasonable speculation, you could require the other side to give proof that their manufacturing methods were different from yours.

 

 

Insiders have different viewpoints on the problem of whether TCM modernization and internationalization strategies are feasible. Some believe that the development of TCM is to pass the international testing standards and reach out to the world. Some think that the development of TCM has its particularity and many TCM elements are not stable; as the development of TCM cannot be separated from TCM doctors, only when the TCM culture is integrated with TCM itself, can a better development come into being. Ding Yongling, deputy general manager of the Beijing Tongrentong (TRT Group) Co., Ltd. expressed in an interview with People’s Daily that “To persuade westerners who don’t believe TCM to go to the TCM doctors should start with the transmitting of TCM culture.”

 

Currently, the U.S. FDA’s testing standards are regarded by the world as the strictest and most effective. The FDA has a sound and comprehensive review system and is recognized by medical institutions and consumers as “the gold standard” of new drug approval. Successfully entering the U.S. market means that you can successfully enter the European, Japanese or other major worldwide markets. However, to pass the three phases of clinical trials of the U.S. FDA takes six to eight years. The cost is estimated at USD 80 to 100 million. In some countries, because of the lack of legal status, it is illegal to practice TCM; TCM drugs cannot be sold to the public and the use of TCM is not included in health insurance.

 

At the end of 1997, compound Salvia dripping pills produced (CSDP) by the Tasly company officially obtained the approval of the U.S. FDA clinical review, and became the first TCM compound approved by the U.S. FDA. However, due to its wide gap with the requirements of FDA, the registration had run aground. Ten years later a re-application was filed. Yan Xijun, chairman of Tasly, admitted that CSDP had paid FDA a lot to reach the current stage, and is deserving of the words “taking ten years to sharpen a sword (persistence is the key to success).” It is known that TCM sold in foreign countries exists in the form of health food. Li Lianda, academician of the Chinese Academy of Engineering said, “If TCM wants to go international, it should go out in a statute of prescription drug rather than health food. But now we are still far away from entering the mainstream of foreign health care system.”

 

The holdup for TCM, which is determined to go on, is not only limited to testing problems. Money is also a big dilemma. The European Directive on Traditional Herbal Medicinal Products 2011 is approaching the deadline. The management of herbal medicinal products in Europe becomes increasingly stringent. Whether it is Chinese company or TCM practitioner in Europe, all will face significant operational risks.

 

Liu Zhanglin, vice president of China Chamber of Commerce, said that after 2011 the costs of registering TCM in Europe would increase by 100 fold. The current cost via the simple registration in Europe is about 10 million Yuan, which medium and large pharmaceutical companies can afford. Nevertheless, after 2011, the cost of drug registration in Europe will increase to nearly 1 billion Yuan, and companies will be confronted with greater difficulties when going through regular registration channels.

 

Since this road is so rough, perhaps Chinese enterprises should take precautionary measures and find another approach. However, whether to go out or not, the development of TCM should be based on innovation and protection.