Song Ruilin, President of China Council for the promotion of drugs: after the vaccine incident, the reform of drug regulatory system cannot be abandoned halfway

Changchun Changsheng vaccine incident has aroused the highest level of attention of the whole society and the country since it was exposed in mid July At present, the investigation and accountability of this incident are still in progress At the same time, the reform of China's drug regulatory system has become a hot topic in the outside world In response to the regulatory loopholes exposed in the vaccine incident, and how to continue the reform of China's drug regulatory system and other related issues, interface news recently interviewed Professor Song Ruilin, executive chairman of China pharmaceutical innovation promotion association and researcher of National Center for drug policy and industrial economics of China Pharmaceutical University In Song Ruilin's view, the vaccine incident revealed that China's drug regulatory system is relatively weak in daily supervision and there are loopholes He also said that the problems in the vaccine incident were not brought about by the reform, but rather that we should deepen the reform The demand for reform is not no longer absent, but greater In fact, since the establishment of SDA in 1998, China's drug regulatory system and system have changed several times in the past two decades, and drug regulatory agencies have been constantly split, merged or reorganized In 2018, the newly implemented drug regulatory system reform established a new General Administration of market supervision, and established a drug regulatory authority (at the Deputy level) under the General Administration of market supervision On the other hand, in terms of specific supervision, since 2015, the state drug regulatory department has implemented a drastic combination of reform, launched a number of reform measures, such as consistency evaluation of generic drugs, significantly reducing the approval time of each link of new drugs Song said that it is an indisputable fact that the drug regulatory reform in the past three years has exceeded the sum of the previous three decades No matter in pharmaceutical innovation, international development or regulatory model transformation, drug regulatory departments have made efforts In fact, it is precisely because of the three years of continuous strengthening of the flight inspection system that the drug regulatory authorities can take immediate action and take remedial measures after the vaccine incident "At present, China is still exploring what kind of drug regulatory system is scientific regulation." "In fact, drugs need the most strict supervision, which is centralized rather than local supervision," Song said in an interview The more vertical and fair its supervision is, the less it will be interfered by the local government, because this kind of management is not responsible for people, only for the drugs themselves, "Song said Vaccine incident exposed weak interface news of daily supervision: Changchun Changsheng vaccine incident investigation and accountability are still in progress From the perspective of supervision, what problems have been exposed in the field of vaccine production and supervision in China? Song Ruilin: first of all, I think the daily supervision is relatively weak and there are loopholes In the event of long-term vaccine, the potency of DPT was unqualified In fact, the State Drug Administration found it in 2017 when it took the initiative to check, but at that time, it was only responsible for punishing the local bureau (Jilin Provincial Drug Administration) for handling, but the local drug administration did not deal with it for a long time Until the rabies vaccine problem broke out later, they rushed to deal with it, resulting in a large number of questions The vaccine has been inoculated In fact, the central supervision is not in place, and the local bureau has not continued to follow up and urge the follow-up processing Secondly, there is a lack of moral education for enterprises in drug administration, and businessmen can ignore morality But the root cause is still the problem of daily supervision, which only stays in the punishment, but does not pay attention to the usual supervision Interface news: how do you evaluate the response and handling measures of SFDA in this vaccine incident? Song Ruilin: objectively speaking, the response of the State Food and drug administration is very fast, but the disposal measures are missing, because the current specific administrative penalties are given to the provincial level, and the administrative penalties to the local bureaus are relatively light, which is our system problem As a matter of fact, the State Drug Administration found the problem of breaking through everything when it made a routine inspection last year, After that, it also released a timely introduction to the society on the disposal of the unqualified products with the titer index of DPT vaccine and punished Jilin food and Drug Administration for taking back the quarantine certificate In fact, the State Food and drug administration is not completely negligent of its duties, but it believes too much in the local food and drug administration The local food and drug administration did not deal with it and the State Food and drug administration did not continue to follow up, forming a loophole If at that time the State Food and Drug Administration quickly arranged for the working group to move in and required that it must be recalled within a certain period of time, the situation would not be like today Therefore, in the future, the State Food and drug administration should have the right of direct punishment for major drug incidents After all, there are some local protections more or less in the local areas If they are not paid attention to, it will eventually lead to major disasters Interface news: will the adjustment of the personnel of the drug supervision system caused by the accountability of the Changsheng vaccine event affect the drug supervision reform process? Song Ruilin: drug regulatory reform is a decision made by the party and the State Council It should not change because of a specific case What's more, the problems in the vaccine incident are not brought about by the reform Instead, it shows that we should deepen the reform The demand for reform is not no longer absent, but greater Will the resignation of Bi Jingquan affect the reform of drug review and approval? Before Bi Jingquan, no one pushed forward the reform of drug review and approval system After he took office, he pushed forward the reform However, the reform was not a matter of Bi Jingquan alone, but his reform ideas were recognized and strongly supported by the central government We often say that "following the law is not enough for us", and whether the reform can continue or not depends on people Therefore, we should now expect the heads of drug regulatory departments to act in strict accordance with the central discipline principles and laws and regulations, so that the reform can continue Interface news: what do you think needs to be done in the reform of China's drug regulatory system after the vaccine incident? Song Ruilin: we need to think hard and continue to adhere to the right direction of reform We can't give up halfway At the same time, we need to improve laws and regulations, and speed up the revision of the drug administration law Drugs need the most strict and professional supervision interface news: the State Food and drug administration was established in 1998, and the food and drug supervision system has changed several times in the past 20 years What is the overall direction of change? What problems do you always want to solve? Song Ruilin: I think it is possible to explore what kind of regulatory system is scientific regulation at the national level For a long time, the state has attached great importance to the professionalism of drug regulation, but we are still exploring how to establish a scientific regulatory mechanism In fact, the most stringent regulation of drugs is centralized rather than local regulation Just like Jilin food and drug administration at that time may consider such issues as workers' layoffs and taxes, so when the vaccine problem is exposed, they will instinctively cover and protect it At this time, the local supervision agencies are not responsible to the central government, but to the local government International experience has proved that the supervision power of products related to human health should be under the unified leadership of the central government In the United Kingdom and the United States, Canada and Australia under the federal system, the state or provincial governments under their jurisdiction can formulate local constitutions, but they cannot formulate laws and regulations to approve and regulate food and drug The drug regulatory power must come from the central government But to achieve this, we need to reduce civil servants and institutions in the process of reform, and there are obstacles, so it is easy to become a mere formality Moreover, if we put drugs and ordinary commodities under the same regulatory system, there will be problems Every country has its own system of drug regulation If we grasp the drug with one hand, it will be very worrisome Interface news: what is the context of China's drug regulatory reform? Song Ruilin: we have been wandering between professional supervision and comprehensive supervision, in such a tangle Therefore, in the past 20 years, China's drug regulatory agencies have been constantly splitting, merging or restructuring, which is very unstable In fact, we should take drug regulation as a special topic, put aside the establishment and institutional setting, and first answer the question of how drugs should be regulated So drug regulation, it is more to be responsible for data That is to say, we say that the quality of this drug is unqualified Why is it unqualified? You have to come up with the test data So who does the data depend on? Not by which director, which director, which team leader, but by the laboratory Interface news: will comprehensive law enforcement dilute professional supervision? How do you view the first mock exam model? Song Ruilin: comprehensive law enforcement depends on whether it is a large-scale comprehensive law enforcement or a small-scale comprehensive law enforcement In fact, public health related law enforcement can be integrated, but it cannot be integrated with non-public health goods, so how to integrate law enforcement also needs to be studied I don't think there is any problem with the mode of "big market - special drugs", but drugs must be managed in a single way, not to say that it's OK to set up a separate department in charge of drugs This is not enough, because the safety management is needed behind the drug The drug does not require complete safety The purpose of our supervision is to make the safety of the drug controllable We allow it to have side effects, but the side effects and positive effects need to be controlled in a reasonable range, so it is very different from other products, so the drug supervision is very professional Interface news: you just mentioned that drug regulation needs centralized power Zheng Xiaoyu once emphasized the power of local approval, but in the process of upgrading the landmark to the national standard, he created a "rent-seeking space" for illegal enterprises Since 2017, the drug regulatory bureau has also proposed to return the regulatory power to the Provincial Bureau Will there be the same problem as that year? Song Ruilin: actually, it doesn't matter who is in charge of illegal enterprise rent-seeking and drug supervision As long as someone is in charge, there will be enterprises that want to rent-seeking, which is a problem of human management But we must return to the question of what is the supervision of drug regulation We need to supervise the quality of drugs rather than the supervisors, so it is not that the increase of institutions and personnel can better supervise Since 2001, China has implemented the vertical management under the provincial level for drug supervision At that time, considering that the local government may not be able to implement drug supervision, you will find that the more vertical and fair it is, the less interference it will receive from the local government, because this management mode is not responsible for people, but only for the drug itself So I always think that if it is necessary for local governments to manage the administrative functions and powers of the province and below, the bottom line is that their drug testing agencies should be vertical Interface news: in the past three years, China has made a lot of efforts to improve the drug regulatory system, and the industry is also very recognized How do you evaluate the reform in the past three years? Song Ruilin: Although there are still some policies to encourage China's pharmaceutical innovation that need to be implemented, some policies need to be connected, and even some policies need to be further improved, it is an indisputable fact that the pharmaceutical regulatory reform in the past three years has exceeded the sum of the previous three decades No matter in pharmaceutical innovation, international development or regulatory model transformation, drug regulatory departments have made efforts In fact, it is precisely because of the continuous strengthening of the flight inspection system in these three years that the drug regulatory authorities