In this year's "Two Sessions", the development of traditional Chinese medicine has once again become a hot topic in the industry. In 2023, the centralized procurement of proprietary Chinese medicines and traditional Chinese medicine formula granules, as well as the promotion of DIP DRG, have caused considerable challenges to the Chinese medicine industry.
Traditional Chinese medicine is constantly making breakthroughs and innovations, and the threshold is not lower than that of Western medicine. At this year's two sessions,Xiao Wei, deputy to the National People's Congress, academician of the Chinese Academy of Engineering, and chairman of Kangyuan PharmaceuticalThe recommendations are straightforward: public hospitals at all levels should eliminate discrimination against proprietary Chinese medicines, especially innovative Chinese medicines, and remove all kinds of restrictions on the use of proprietary Chinese medicines.
Xiao Wei further proposed that the combined use of traditional Chinese medicine and Western medicine should be encouraged in the clinical diagnosis and treatment of diseasesIn particular, proprietary Chinese medicines should be exhausted.
There are also those who cheer and cheer for traditional Chinese medicineZhang Boli, deputy to the National People's Congress and academician of the Chinese Academy of Engineering。This is already the 17th year of Zhang Boli's tenure as a representative of the National People's Congress, this year he brought to speed up the establishment of a traditional Chinese medicine knowledge protection system, strengthen the formulation of quality standards for traditional Chinese medicine formula granules, etc., he said: The modernization of traditional Chinese medicine has a lot to do, and there is a lot to do.
China has been actively advocating the integration of traditional Chinese medicine and Western medicine, but in reality, there are still many discrimination and prejudices against traditional Chinese medicine.
Xiao Wei said for example, at present, many comprehensive hospitals have misunderstandings about traditional Chinese medicine, discriminating that chemical drugs have exact efficacy, and there is no strong evidence-based medical basis for Chinese patent medicine.
This situation is even more pronounced under the hammer of anti-corruption:In order to avoid risks, many doctors follow the most conservative clinical guidelines to prescribe medicines, resulting in proprietary Chinese medicines becoming the most affected area by anti-corruption.
Xiao Wei suggested that the National Health Commission and the State Administration of Traditional Chinese Medicine should formulate policies for the clinical application of proprietary Chinese medicines in public clinical hospitalsThe use of proprietary Chinese medicines is encouraged to the greatest extent possible.
Xiao Wei also mentioned that the guidance on the use of new Chinese medicines developed according to ancient classic prescriptions is not clearGeneral hospitals should prescribe and dispense medicines according to the syndrome of traditional Chinese medicine, and Western doctors are not allowed to prescribe and use them, and they are in an embarrassing situationdampen the enthusiasm of enterprises for R&D.
The innovation of traditional Chinese medicine itself is not easy, Xiao Wei also specifically mentioned the plight of innovative traditional Chinese medicine, under the general discrimination against traditional Chinese medicine, innovative traditional Chinese medicine drugs have not been spared.
In the past two years, with the active promotion of the state, the overall investment in traditional Chinese medicine research and development has been increasing, and many traditional Chinese medicine pharmaceutical companies have built their own research and development teams, and traditional Chinese medicine CRO has also become a hot topic. In February 2023, the State Food and Drug Administration issued the "Special Provisions on the Registration and Administration of Traditional Chinese Medicine" to encourage the development of new traditional Chinese medicine drugs, strengthen registration management, and set off a wave of research and development of innovative traditional Chinese medicine drugs.
According to the 2023 drug evaluation report, 54 innovative Chinese medicines have been declared for clinical use, a year-on-year increase of nearly 40%. The current innovation of traditional Chinese medicine is strictly in accordance with the standards of Western medicine, clinical trials must be conducted, and the design of clinical endpoints must also be objectiveMoreover, the evaluation will take into account whether there are clear advantages to the existing ** options. Products that can be approved have a great guarantee of clinical value, and should enjoy the same market access treatment as chemical innovative drugs.
Geng Funeng, deputy to the National People's Congress and chairman of Good Doctor Pharmaceutical GroupIt is believed that the new measures for the protection of proprietary Chinese medicine varieties are an important driving force for the high-quality development of traditional Chinese medicine.
In December 2022, the State Food and Drug Administration announced the Regulations on the Protection of Traditional Chinese Medicine Varieties (Draft Revisions for Solicitation of Comments), but now more than a year later, the revised version of the regulations has not been released.
The draft for comments provides great policy convenience for the protected varieties of traditional Chinese medicines: those assessed as first-class protection will be given ten-year market exclusivity; second-level protection, given five-year market exclusivity; Regardless of the level of protection, priority will be given to the selection of the basic drug catalog, diagnostic guidelines and clinical pathways, and special treatment will also be given to hospitals in bidding and procurement. Therefore, companies are very much looking forward to the publication of the revised version.
Deputy to the National People's Congress, Zhao Jing, chairman of Jilin Tonghua Guhong PharmaceuticalIt is suggested that the protection of intellectual property rights of traditional Chinese medicine should be strengthened, and an intellectual property protection system should be established that conforms to the characteristics of traditional Chinese medicine and can solve practical problems.
Previously, some committee members proposed that Japan and South Korea accounted for as much as 8 to 90% of the world's traditional Chinese medicine shareJapan accounts for 70% of patent applications related to traditional Chinese medicine.
Zhao Jing suggested that attention should be paid to the excavation and innovation of ancient Chinese medicine books, the establishment of an incentive mechanism and database for the excavation of ancient formulas, and the full mobilization of Chinese medicine scholars and folk Chinese medicine experts to participate in the development and sorting of ancient Chinese medicine books, and pay attention to the protection of copyrights, patents and trade secrets while excavating and innovating ancient formulas. Encourage traditional Chinese medicine enterprises to strengthen the operation of intellectual property rights of traditional Chinese medicine.
This coincides with Academician Zhang Boli's proposal. Zhang Boli pointed outTraditional knowledge of traditional Chinese medicine is threatened by mutation and lossThere are situations of "improper possession" and "improper use", and the current intellectual property system is difficult to meet the needs of protecting traditional knowledge of traditional Chinese medicine. It is urgent to explore the establishment of a special protection system for traditional Chinese medicine.
To this end he suggestsFormulate regulations on the protection of traditional knowledge of traditional Chinese medicine as soon as possible, publish the "List of Traditional Chinese Medicine Knowledge Protection", and set up the "Traditional Chinese Medicine Knowledge Management Committee".
Written by |Li Ao.
Edit |Jiang Yun Jia Ting.
Operations |Valley.
Illustration |Visual China.
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