Interview with Yao Zhi: high investment, high risk and low price, do you dare to continue to add?

Song Minxian, deputy director general of Sichuan Pharmaceutical Association and director of China Pharmaceutical Association implemented the "four strictest", a little carelessness is the unprecedented punishment of family destruction, which is the deepest feeling of the newly revised Drug Management Law (hereinafter referred to as the new law) to song Minxian, a senior lawyer in the industry Lawyer song once served as the deputy director of the drug administration department of the Department of health of Sichuan Province, the director of the drug registration department and the director of the laws and Regulations Department of Sichuan food and drug administration He had profound insight into the drug management law In the face of the new law's punishment, lawyer song was deeply shocked "The punishment has been strengthened, with a fine of 9.1 billion yuan in the case of longevity biology and more than 30 billion yuan in accordance with the new law In 2016, Anhui Province announced two cases of Ginkgo biloba extract preparation, one of which is 3.64 million confiscated funds According to the current standard of the new law, only the fine should be 18.2 million The value of the other goods is more than 300000 yuan, which should be fined 3.55 million yuan according to the current minimum standard In addition, according to the annual report of the State Food and drug administration, in 2017, more than 110000 drug cases were investigated and dealt with nationwide, with a value of 330 million yuan According to the new law, more than 110 billion yuan to 360 billion yuan should be fined Do you think they will not lose their money? " High investment, high risk and low price, dare you continue to raise? In 2015, the drug policy storm came one after another After the amendment of the new law, the drug market has basically formed a pattern of high investment, high risk and low price This year's pharmaceutical economy is likely to show negative growth, and lawyer song conservatively estimates that half of domestic enterprises will no longer be suitable for medicine Asked about the biggest impact of the changes in the new law on current enterprises, lawyer Song told yaozhi.com: "the biggest impact is that they need to assess whether they are still suitable for medicine." The industry is making up lessons The previous batch of drugs now need to be supplemented with consistency evaluation If they fail to pass the customs clearance, they will be finished in vain The evaluation of marketed drugs, injection preparations and traditional Chinese medicine may be carried out in batches and accelerated The conclusion and basis of public approval of drug registration and other information, enterprises without the ability to make up lessons can not reach the threshold of the game, or transform or integrate rational choice Only when someone exits can the industry become bigger and stronger The remaining enterprises with continuous R & D capability need to assess whether your varieties have clinical value, whether there is capital investment for new drugs and listed drugs research, whether there is enough ability and strength to wait for research results, whether they can withstand risks and take time High risk and high input games only welcome the warriors of the times, a group of warriors who still choose Nirvana after careful consideration " These enterprises need to strengthen risk control capacity building and conduct risk control immediately while assessing risks "Lawyer Song told Yao Zhiwang Warning: the holder is in the risk vortex, the new law is strict, and the responsibility is new Among them, the listing permit holder system is full of new ideas, stipulating that the holder is responsible for the whole life cycle of the drug Song lawyer's statement on this responsibility needs to be refined in practice "The new law stipulates that the holder shall be responsible for the safety, effectiveness and quality controllability of the drugs in the whole process of production, sale and use How does the holder bear the responsibility for the unreasonable use of drugs by the drug using unit? How to solve the problem of application of law should be recognized in practice in the relevant provisions of product liability and medical damage liability in tort liability law " Lawyer Song said that from the legal point of view, responsibility and power are corresponding, and they should be given power while giving responsibility The holder is responsible for the quality in the process of drug use, but does not interfere with the right of clinical drug use The drug using unit is responsible for the behavior in the process of drug use The refinement of the responsibility in the holder system and the reasonable sharing of risk will help to reduce the risk At last, the lawyer of Song Dynasty proposed on the spot At present, the State Food and drug administration is working hard to revise the supporting system of the new law, actively participating in the consultation of various system revisions, and making suggestions through relevant associations and societies, which is conducive to the correct and comprehensive implementation of the principles stipulated in the new law Editor in charge | sulfur statement: this opinion only represents the author himself, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.