Traditional Chinese medicine: research and development is the process of how to actually protect the?

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        Traditional Chinese medicine confidential varieties: umbrella development crisis

        "Prescription cannot be made public, second development is hard to do." This is a Chinese traditional medicine enterprise of not long ago a leadership when accepting a reporter to interview a complaint.

        According to introducing, this enterprise has a national Chinese medicine confidential varieties, prescription has been won the country confidential. In order to improve the technology of products, the enterprise has been committed to the second development of products. But because the product "identity" special, carries on the second development means to researchers public prescription. Although these researchers are signed by the regulation to lifelong confidentiality agreement, but the enterprise or worry about prescription were leaked. Out of this concern, the enterprise have been afraid to and the outside research institutes, can rely on internal research and development institutions for the development, thus affecting the product second development process.

        For the enterprise is concerned, the traditional Chinese medicine confidential varieties is like a double-edged sword, in guaranteeing the product from the copied also bound his own feet and hands. This case reflects a few dazzling aura of crisis behind products.

        The enterprise is the complex psychological

        According to jinan university institute of traditional Chinese medicine and natural medicine professor YeWenCai introduction, traditional Chinese medicine research results of the existing protection forms included: national secret prescription protection (such as yunnan baiyao, nightfall pill, etc), trademark protection (such as colleague hall, at king cabinet, etc) and administrative protection (such as new drug protection, variety of traditional Chinese medicines protection) and patent protection, etc.

        One secret recipe for the current domestic country to the highest level of protection of traditional Chinese medicine, national the secrecy law protection.

        It is reported, the domestic now only of yunnan baiyao, wang Huang, Ann palace bezoar pills, pills, hua tuo reengineering nightfall shot five national secret prescription, the five product in the traditional Chinese medicine product is in the "national treasure". Because get the prescription secret, these products have been sold in the same products in the front in the whole country. In strange star pharmaceutical hua tuo reengineering pill, for example, due to begin from 1985 is listed as confidential prescription, this product 1992 sales will break through the 1, last year's sales of 180 million yuan.

        The Chinese traditional medicine in several other is also "bomb" class products. Both of Huang zhangzhou young, or in yunnan baiyao for enterprise earn to rolling profits. Not long ago capital big alligator DongCheng group at the high price of 750 million yuan in cloud medicine group, in the final analysis, seeing the yunnan baiyao is the gold-lettered signboard.

        YeWenCai think, this 5 product is able to obtain the highest protection, because it has the unique effect. "Like the original paper, its technology national treasure has not publicly. Many enterprise because of the protection of the state, then sit enjoy exclusive production advantage, sales, however, need not be anxious. Every coin has two sides. Got such a good protection measures, the enterprise to remain the same, this natural product against the connotation of apparently technology improve."

        So, the expert thinks, the home of a few big secret products are basically the traditional thing, and no further to research and development.

        However, the question is, once to second development, must be earnest effort to make these confidential varieties of the active material and internal mechanism to improve production process and quality standards, which will involve the modernization of traditional Chinese medicine to many of the category. To do the research, the enterprise must to the researchers public prescription, although in the study and external research organization the signing of the relevant confidentiality agreement, but as the article of the beginning of the scene, the vast majority have confidential varieties of traditional Chinese medicines are afraid of prescription enterprise leaked concern, so would rather choose in the enterprise internal second development, to the outside and research institutes.

        Long engaged in traditional Chinese medicine and natural drug research and development work of the Chinese academy of engineering YaoXinSheng when accepting a reporter to interview, he said, have met many examples of this. YaoXinSheng told reporters, his handling of the research organization used to think and enterprise cooperation, carries on some Chinese herbal medicine of confidential varieties development, but "to open a prescription, must obtain the approval of the relevant departments, not just can't do it. What's more, general approval of the enterprise are not willing to open, so we always have had no opportunity to involved in these products research."

        The China traditional Chinese medicine journal deputy editor weeks extraordinary analysis road, if listed as confidential varieties of words, prescription is not optional for researchers to read. He also revealed two months before in state pharmacopoeia committee of a meeting, had the confidentiality of the flora pharmacopoeia prescription drug prescription announced whether to dose, and discussed, the meeting have many enterprises have to actively declare secret prescription, therefore, this to the benefits of the enterprise is very big, "but there is still no clear results."

        Avoid the repeated the fate of the paper

        "Even if is national security is a kind of passive defense type protection, to really not be copied the protection of patent right of way to go on." YeWenCai said, these confidential varieties of protection way with foreign practice to patent protection standards.

        "Prescription is confidential, but the return or there are some who are know, this prescription and no its several years will not be leak out. And those who know the people in private prescription in case study research also have no, and they make it clear, after may shake the body into another new drugs on the market." ZhongYaoJie one expert is worried about to say.

        According to information, at present each big multinational pharmaceutical enterprise of traditional Chinese medicine and natural drug increase, already has several foreign capital enterprise research institutions in Shanghai zhangjiang science park, they a very important work is to collect Chinese classic gu fang, prescription, and then get foreign companies in research and development.

        "When the paper is not like this? The process has been in secret, but finally being stolen." The experts said.

        YeWenCai think that, in the long run, want to make Chinese medicine from the fate of the paper confidential varieties, the only way out is to walk road of patent protection and technical standard strategies, namely enterprise should take the initiative to confidential varieties were thorough research, make clear the function mechanism and related material foundation, inject new scientific connotation, and then apply for patent. In addition, by dramatically confidential varieties of traditional Chinese medicine quality standard, also can achieve the purpose of building technical barriers.

        Guangzhou qixing pharmaceutical production technology responsible for one person said, patent protection is the inevitable trend of the future, but it was not going to give up qixing hua tuo reengineering the confidentiality of the prescription pills. They will be positive for secondary development, the research results apply for patent protection. He thinks, this kind of means more suitable for protection is carried out research of traditional Chinese medicine unique varieties. "In the current domestic intellectual property rights of the environment, the public can be obtained, but the patent prescription maintenance rights and interests are infringed upon cost is high." He said.

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        The recently unified cleaning confidential varieties of traditional Chinese medicine

        Traditional Chinese medicine is confidential varieties according to the law of the People's Republic of state secrets law ", "scientific and technological secrets regulations (the state science and technology commission, state secrecy bureau 1995 order 20) and other relevant provisions, already listed in the national secret technology project, the varieties of traditional Chinese medicines. In order to strengthen the supervision and administration of traditional Chinese medicine confidential varieties, SFDA to all the national drug standards will be in prescription, the dose, the content such as public or no method not fully open the varieties of traditional Chinese medicines (hereinafter referred to as "not public standard varieties of traditional Chinese medicines") undertake unity to clear. As for not listed in the national secret technology project "the standard variety of traditional Chinese medicines not public," SFDA are confidential varieties according to the management, and

        According to the regulations of the public its quality standard prescription, the dose, the method and other related content.

        One, "the standard variety of traditional Chinese medicines not public" production enterprise, such as applications will be listed in the state this variety secret technology project, according to the national science and technology secret office "about the country's secret technology to work for the secret" notice of declaration requirements, to the enterprise locus provincial level the (food and drug supervision and administration departments apply for them.

        Second, each provincial (food and drug supervision and administration department for the authenticity of the filing materials, integrity, and normative audit, and will review opinions and declare material, in May 2005 by 25 th confidential way formally submitted to SFDA.

        Three, to report all the materials SFDA summarize and unified examination, and will review comment and related materials submitted to the national science and technology secret office for examination and approval. The national science and technology secret office will in the end of 2005 before the results of examination and approval shall be internal notice, and the release of the state secret technology project certificate ".

        Fourth, to already obtained "state secrets technology project, certificate of variety of traditional Chinese medicine, by SFDA confidential varieties management. In its secrecy period, stop the variety and the examination and approval of the acceptance for national standard drugs registration application form, change or change of administration way for application for registration.