Characteristics of traditional Chinese medicine and current situation of intellectual property rights
Traditional Chinese medicine has a completely different medical theoretical basis from western medicine. The theoretical basis of traditional Chinese medicine is the theory of yin and yang, five elements, luck, viscera, meridians and other theories, as well as etiology, pathogenesis, diagnosis, syndrome differentiation, treatment principles, prevention and health preservation. In modern science, Chinese medicine embodies the holistic and related viewpoints in system science, which is related to China's ancient philosophy, cultural tradition and even political views. The characteristics of western medicine are in the same strain as the philosophical thought of western reductionism.
Forcibly demanding modernization and westernization of Chinese medicine, ignoring the characteristics of Chinese medicine's own diagnosis and treatment, and failing to combine the advantages of Chinese and western medicine are often tampering with the theoretical thinking of Chinese medicine, and the result is essentially a western medicine. The development of Chinese medicine can only adapt to the modern society and develop continuously on the basis of its own system, but it is not the right way to transform it from the perspective of western medicine. To this end, Zhang Wei, director of the Drug Registration Department of the US Food and Drug Administration, announced on June 8, 2008 that in order to follow the laws of traditional Chinese medicine, reflect the characteristics of traditional Chinese medicine and encourage innovation, the agency officially promulgated and implemented the Supplementary Provisions on the Administration of Registration of Traditional Chinese Medicine. This regulation shows that the ancient classical prescription preparation has been used in clinic for a long time and its curative effect is exact, and it does not require animal experiments to prove its curative effect, nor does it require clinical research. "
In addition, the strength of western medicine treatment is to treat emergencies. Traditional Chinese medicine has been tested by China's experience in fighting diseases for thousands of years. Some of its viewpoints, such as preventing diseases and paying attention to aftercare, have made great contributions and obvious advantages to safeguarding people's life and health and improving people's quality of life. At the same time, the price of traditional Chinese medicine is lower than that of western medicine, and it is more easily accepted by the general public. At present, Chinese medicine is declining and neglected, and the marginalization phenomenon is influenced by the invasion of western culture and national nihilism. This is not conducive to the improvement of people's health in China. The Chinese medicine community throughout the country must support the development of Chinese medicine and let the ancient Chinese medicine continue to serve the people's health.
Although Chinese medicine has an inherent market in the Chinese cultural circle, including overseas Chinese, Southeast Asia, Japan and South Korea, there are still some problems to be overcome in order to open the European and American markets. For example, some traditional Chinese medicine prescriptions with remarkable curative effects are the crystallization of thousands of years' wisdom of China people, but they are often reluctant to invest and develop in China, so that they cannot meet the safe and effective treatment standards and cannot be industrialized. On the contrary, it is often foreigners who invest first and then sell them back to China at a high price. Typical examples, such as Ginkgo biloba extract as an anticancer drug, made in Germany, passed FDA standards and achieved great success in the world market. In order to reach the European and American standards and occupy the European and American markets, traditional Chinese medicine can be used as a plant medicine, and the effective components in traditional Chinese medicine can be found through extraction. Because Europeans and Americans don't like compound Chinese medicine for reasons of drug quality and economy. It is difficult enough to find one kind of Chinese medicine, not to mention dozens of kinds, such as Ginkgo biloba products. The classic drug "Liuwei Dihuang Pill" contains six kinds of traditional Chinese medicines, and it is said that it can cure 200 diseases. Coupled with various influencing factors such as the place of origin, it is very difficult to analyze and verify, and quality control and patent protection are even more difficult. Although Chinese medicine likes to emphasize the individualization of Chinese medicine application, as a medicine, it should emphasize its * * * nature if it wants to enter the international market. First of all, we should strive to implement the international common standards of "safety, effectiveness, stability and controllability".
The research and development of innovative drugs, including chemical drugs and biological drugs, is a multidisciplinary, cross-industry and technology-intensive system engineering, with large investment, long cycle and high risk, and it is also an international industry. At present, the average cost of developing a new drug is about $300 million, which takes an average of 65,438+02 years. Only from 8000 to 10000 compounds can a compound be finally approved for marketing. Large pharmaceutical companies in the world generally spend 10% ~ 15% of their sales on new drug research and development. However, there is a big gap between China and western countries in the capital investment, research level, research conditions and the number of researchers in new drug research and development. Under the realistic conditions of our country, these investments are unimaginable and unbearable not only at present, but also in the foreseeable future. Therefore, on the whole, China's new drug creation can not directly enter the stage of technological innovation, but must go through the stage of imitation innovation. First, develop a "me too" drug, that is, generic drugs, and then gradually transition to the stage of technological innovation.
To develop "I also" medicine on a large scale in China, we must do the following: First, change the concept and mechanism, don't excessively pursue technological innovation, excessively pursue achievements and publish papers, and take profit maximization as the ultimate goal; Second, due to the limited financial support, the development of "Woye" drugs must take the road of joint research institutions and enterprises, increase the investment of enterprises, solve the problem of serious shortage of research funds, and gradually transition to enterprises to become the main body of new drug research through the enjoyment of results; Thirdly, molecular modification of new and successful breakthrough drugs or new drugs developed by other ways (including "I also" way) is carried out to find new drugs with the same or similar mechanism of action and certain characteristics in treatment. This includes: (1) reorganizing new drugs (such as paclitaxel) without patent protection as soon as possible to form their own intellectual property protection; (2) For new drugs with patent protection, we can make in-depth research on the scope of patent protection, carry out patent edge innovation without infringing others' patents, and consciously change the local chemical structure. For example, the development of pro-drugs with enhanced water solubility or fat solubility will help to change bioavailability, block metabolic transformation in vivo and prolong drug efficacy, so it will be possible to obtain new drugs with stronger drug efficacy than the mother; (3) Pay attention to the development of chiral drugs. If the past racemic drugs are re-studied, it is possible to develop new "me-too drugs", such as Nifedipine, a calcium channel blocker in Japan, and two chiral "me-too drugs" such as Banidipine and Binidipine have been successfully developed. In short, if we blindly pursue technological innovation now, it is not realistic in terms of research level, strength, funds and research conditions. As far as the whole country is concerned, the imitation innovation strategy must be implemented in the primary stage of new drug research in China, and the technology and funds needed for new drug research and development must be accumulated through imitation innovation. At the same time, with the enhancement of technical strength and economy, it will gradually transition to technological innovation, which includes the use of brand-new mechanisms and brand-new structures for drug design. But even so, the development of "I also medicine" is still an important way to develop new drugs faster and more economically.
In 2008, the global pharmaceutical market grew by 5% ~ 6%, and the market sales reached 735 billion ~ 745 billion US dollars. Some pharmaceutical patents with annual sales of about $20 billion in the world have expired, equivalent to the sum of the previous two years. These include products such as Risperdl. Fosamax, Topomax, Lamictal and Depakote have ended their market monopoly in many mainstream markets around the world, and promoted the growth of generic drug market at the rate of 14% ~ 15%, reaching more than 70 billion dollars. In 2008, more than two-thirds of prescription drugs in the United States were generic drugs. The newly implemented government contract plan in Germany and the educational programs in Japan, Spain and Italy have made generic drugs more widely used in the above markets. In addition, multinational companies such as GlaxoSmithKline and AstraZeneca have moved their production bases to China, and many multinational companies continue to set up more R&D centers in China. Driven by the trend of global pharmaceutical manufacturing centers moving to Asia, more and more enterprises in China will copy expired patented products, undertake more international production of raw material drug preparations and other products, outsource research and development, carry out entrusted clinical trials of drugs, and participate in international division of labor and cooperation more widely. For example, Wuxi Wuxi WuXi PharmaTech Group seized this opportunity to develop rapidly, and made use of China's low cost and abundant scientific research talents to become the world's leading R&D outsourcing service company for pharmaceuticals, biotechnology and medical devices.
The research and development of biopharmaceuticals is similar to new chemical drugs. Due to the complexity of life science, the research and development of biomedicine can not be as controllable and predictable as the research and development of machinery and electronic communication industries. This can be seen from the writing of patent application documents for biochemistry, which is different from machinery and electricity. Patents in biochemistry must have examples, and inventions involving microorganisms must also provide proof of preservation of cultures before they can be fully disclosed. However, as long as the electromechanical instructions clearly state the composition and logical relationship of each part that constitutes the innovation point, ordinary technicians in the field can realize them without giving examples. This is because biomedical inventions can not be completely explained by mathematical logic, and often need to be repeated by experimental conditions of experimental examples. Therefore, biological research is still in the theoretical research stage, and the scientific research achievements of many scientific research institutes and enterprises are still in the patent literature stage. China has been engaged in upstream research of biomedicine for a shorter time than western countries, and it is unlikely that some upstream targets will become new drugs through follow-up research. There is still a long way to go to realize industrialization and treat human diseases safely and effectively. At present, the mature biopharmaceuticals on the market are still several traditional varieties such as antibody, vaccine and interferon.
Generally speaking, the financial crisis has little impact on the finished medicine industry, because drugs are disposable consumer goods and have little to do with the economic environment. Secondly, the development of pharmaceutical companies mainly depends on their own rolling development, not relying on banks, not relying on funds to promote, and will not be restricted by tight monetary policy. Third, compared with other export-dependent industries, the export proportion of pharmaceutical industry is very small. After China's entry into WTO, China opened its market to overseas pharmaceutical giants, and the main battlefield of the pharmaceutical industry is inside, not outside. Therefore, changes in overseas markets have little impact on domestic pharmaceutical companies. Moreover, with the advancement of medical reform and new rural construction, if universal medical insurance coverage is achieved, the future growth of the pharmaceutical industry will be enormous. I believe that the pharmaceutical industry in China will maintain a high growth rate in the future or even for a long time.
In addition, the financial crisis not only brought rare market access opportunities to the pharmaceutical industry. Due to the lack of follow-up capital investment, many small and medium-sized pharmaceutical R&D institutions overseas hope to seek the cooperation of investors. Powerful pharmaceutical companies in China should pay close attention to the research and evaluation of promising projects and buy valuable research patents. At this time, they can also introduce the production directors, senior managers and management technologies of European, American, German and Japanese pharmaceutical companies at low prices, which is an excellent opportunity to improve themselves.
However, the impact of the future financial crisis on the export of traditional Chinese medicine may gradually increase, and the growth rate of traditional Chinese medicine export will obviously slow down, especially the export of extracts. As the extract is mainly used for industrial purposes such as herbal medicines, dietary supplements and natural cosmetics, the market demand for dietary supplements and natural cosmetics is large, and the financial crisis will lead to shrinking consumption, and the demand for China extract raw materials in the international market will decline. In addition, the market demand for Chinese herbal medicines and decoction pieces is relatively stable, but domestic quality inspection has improved the standards of Chinese herbal medicines and decoction pieces, and many enterprises cannot perform their duties normally, which will greatly affect the future export growth.
In a word, the guiding ideology of China government for pharmaceutical industry is very clear, which is to promote the transformation of economic growth mode and industrial structure and establish enterprises with independent intellectual property rights. Therefore, on the one hand, the government has given strong support to the frontier research of medicine within its financial capacity, on the other hand, it has given many economic subsidies and policy support to high-tech pharmaceutical enterprises. Therefore, Chinese enterprises should make effective use of government policies, strengthen drug research and development with independent intellectual property rights, and achieve greater success in the market.