Drug innovation also needs "river binding and sand flushing"

Source: People's daily 2015-11-03 new drug creation is a major livelihood issue, as well as a major economic and national security issue Recently, no matter the implementation of a new round of drug review and approval system reform, the Nobel Prize in physiology or medicine won by Professor Tu Youyou, or the launch of "major new drug creation" in 2016 under the background of pilot reform, drug innovation has become a hot topic It is worth thinking about how to solve the dilemma of the majority of generic drugs in China for a long time, lead the transformation and upgrading of biomedical industry with technological innovation, and build a healthy China 2020 New drug creation has its own rules, which should not be rushed to success In the past, we tend to pay more attention to the "encouraging development system" and ignore the "restrictive regulatory system" The diversion channel can not only enrich the water, but also make the water clear after the high dam is built The lack of relevant system design leads to a situation of "bad money drives away good money" in the research and development of new drugs The system includes both the development system and the supervision system Only when we fight with both hands can we exert our joint efforts From the perspective of regulatory system, most of the processes of registration and approval, bidding and purchase, and access to medical insurance of some drugs in China are "special affairs and special treatment", and there is no real institutionalized channel of "business and proper treatment" For example, the inconsistency between the review policy and the drug R & D law in the drug review system, coupled with the delay in the review time limit and other issues, hinders the opportunity for new drugs to go on the market; the adverse reaction monitoring system has not formed a linkage, the information island problem is serious, and the guiding role for new drugs improvement has not been shown; the drug delisting system has not been really established, which is difficult to play a role in reversing the development of original innovative drugs for enterprises In the field of circulation management, drug price increase is too high, and market disorder affects drug innovation environment, etc From the perspective of legal regulation, the current legal system related to drug innovation and drug regulation has the problems of "too long regulatory age" and "too many patches" of policies, and the legal system and surrounding support policies are not perfect For example, there are no laws and regulations specifically applicable to the in vitro diagnosis industry, and some new forms of innovation achievements have not been well protected by intellectual property rights These problems also reduce the enthusiasm of enterprises in the creation of new drugs Sometimes, innovation is also inseparable from the institutional conditions of "river binding and sand flushing" According to the communique of the Fifth Plenary Session of the 18th CPC Central Committee, innovation includes not only technological innovation, but also institutional innovation, including policies and regulations In view of various problems in the drug regulatory link in China, it is urgent to improve the evaluation system that plays the role of technical access, improve the pricing and medical insurance system that plays the role of payment and payment sharing, strengthen the monitoring system that plays the role of adverse reactions of pharmaceutical products after listing, and strengthen the disciplinary system that standardizes the pharmaceutical market and social order With a complete system, it can meet the requirements of the system environment for the technical innovation of drugs and preheat the technical innovation in an all-round way Supervision is not only to ensure drug safety, scientific supervision is conducive to drug innovation and enhance the willingness of innovation The creation of pharmaceutical innovation environment needs not only the pull effect of "locomotive" of the national development and Reform Commission and the Ministry of science and technology, but also the linkage and cooperation of all departments in the whole supervision chain, so that the encouraging development system and the limiting supervision system can jointly act on the process of pharmaceutical innovation and improve the impetus of pharmaceutical innovation If the regulatory innovation lags behind, it will seriously hinder the promotion and application of new technologies and products For this reason, it is particularly necessary to speed up the formulation of innovative laws, further improve the intellectual property protection law, at the same time, accelerate the deregulation of policies, release regulatory dividends, and promote Chinese medicine to a higher level.