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In fact, for “old representative†Cai Dongchen, his concern for drug R&D and innovation is consistent. In recent years, both of the “two sessions†submitted by him have related to innovation. In his words, "At the moment, our industry's top priority is innovation."
"Over the years, the unclear definition of 'original medicine' has directly contributed to my proposal for this year." Representative Cai Dongchen told reporters that China currently has many names for innovative drugs, including "independent innovation drugs" and "independent intellectual property rights medicines." , "innovative drugs," "create new drugs," "new research drugs," and so on, which to some extent caused some difficulties in the determination of independent innovation in the pharmaceutical industry, which in turn led to China's encouragement of independent innovation policy is difficult to implement, corporate innovation and investment The output is seriously inconsistent, and it is difficult for companies to become the main body of innovation.
Cai Dongchen representatives also worried that the unclear concept of "original drugs" will also affect the smooth integration of China's pharmaceutical industry with international standards.
According to statistics, in the field of chemical medicine, the most innovative value is for the first time that new compounds are innovative drugs for medical purposes. They are called “original drugs†of NCEs (New Chemical Entities, abbreviated as NCEs) and these drugs are regarded as the highest in foreign countries. Hierarchy of innovative medicines. Internationally, there are clear "original drug" recognition principles or standards, and there are corresponding incentives and protection policies.
According to the introduction of Cai Dongchen, China's current drug registration and other related laws and regulations do not have corresponding definitions and classification standards for the level of independent innovation in pharmaceuticals. Companies expect more encouragement and protection policies. There are more than 70 types of new drugs in China that have been listed and declared since 1985, but the internationally recognized “original drugs†for NCEs are only artemisinin, butylphthalide, bicyclol, epothilone, and hematoporphyrin. , Sodium glycopyrrolate, phenylcyclopentaline hydrochloride and several other products.
Deputy Cai Dongchen said that these “original drugs†that have been heavily invested have not achieved the expected benefits due to non-medicine pricing, drug bidding, and medical insurance catalogs, and have not achieved the demonstration effect of independent innovation.
"In sharp contrast, foreign-funded enterprises have used unreliable concepts such as 'patent drugs' and 'original research drugs' to obtain medicines that have not received special treatment in China. The 'original medicines' in the market place in China . The representative of Cai Dongchen said.
Cai Dongchen pointed out that the "National Medium and Long-Term Plan for Scientific and Technological Development (2006-2020)" and "Eleventh Five-Year Plan for Development of the Pharmaceutical Industry" clearly stated that it encourages independent innovation. "Administrative Measures on National Independent Innovation Product Certification (Trial) It has also been promulgated. Now we need to formulate relevant assessment methods for independent innovation of pharmaceuticals as soon as possible to distinguish our “original medicines†from general level innovation products to reflect the continuity of the state’s encouragement of innovation policies and the fairness and rationality of the protection of “original drugsâ€. .
In the "Proposal to Legalize the Concept of "Original Drugs" in China", Cai Dongchen mentioned that relevant state departments can comprehensively consider the actual situation of China's "original medicines" and the goal and long-term interest of building an "innovative country." Organize experts to study, discuss, and legalize the definition of "original drugs." The relevant concepts and academic definitions of "original medicine" and "original medicine" already proposed by the Chinese Pharmaceutical Association can be referred to, and then refined by experts and discussed in a professional manner.
In the motion, Cai Dongchen said: "For the first time in the world, based on medical purposes, research and development of a natural or synthetic compound, and patent protection for Chinese compound or pharmaceutical use, can be used safely and effectively for prevention. The chemical drugs that treat or diagnose specific diseases are original drugs, and the original drugs that have been approved for listing by the State Food and Drug Administration can be called original drugs."
Cai Dongchen’s representative also suggested that relevant professional departments and policy development departments should actively use the concept of “original medicine†and establish a catalogue of “original medicines†to prioritize the inclusion of safe and effective “original medicines†into the “Government Procurement Catalog†and “National Essential Drugsâ€. Catalogue, “National Basic Medical Insurance and Work Injury Insurance Catalogueâ€; in the pricing segment, the “original medicine†is implemented separately; in the link of medicines entering the hospital, the medical institutions are no longer guided to bid for “original medicines†through direct bidding. Recorded into the hospital to increase the scope of selection of primary hospitals; in the international market development, the guidance of "original drugs" through the market and technology authorization to enter the international market, to ensure "original drugs" in the patent period to maximize the benefits of the international market. Through a relatively special support policy, we will build a good atmosphere for innovation, promote enterprises to become the main body of innovation, and promote the sustainable development of the pharmaceutical industry.
Two sessions: China's concept of "original medicine" should be legalized as soon as possible
During the “two sessionsâ€, Cai Dongchen, deputy to the National People’s Congress and chairman of the Shijiazhuang Group, submitted a “Proposal to Legalize the Concept of "Original Drugs" in China."