First in China! Boao Lecheng released the latest operation data to merge health care and drug regulatory agencies

Author: Wu yeting △ location of Boao Lecheng in Hainan Island In 2013, the State Council drew a circle in Hainan, and China's first and only "medical special zone" -- Boao Lecheng International Medical Tourism pilot zone was launched Among them, the most attractive policy is "new drug special zone", which allows the use of new drugs, new devices and new vaccines that are the most cutting-edge in the world and have not yet been listed in China In 2019, the first area will go to the sixth year It is estimated that the number of medical tourists received in the whole year is about 75000, an increase of 134% year on year; the operating revenue of medical institutions is about 640 million yuan, an increase of 75% year on year "A county hospital can treat hundreds of thousands of patients a year How can tens of thousands of people live in the first area?" On January 11, 2020, Gu Gang, the director of the administration of the Pioneer District, who had been in office for just five months, took the initiative to talk about this question In his opinion, this is related to the fact that the park itself is newly built from rural land acquisition and has no industrial foundation, and everything has to start from the beginning, "transportation is not convenient, you need to change high-speed rail and then change cars to get to the park when you fly to Haikou Before, the supporting facilities were not perfect, and many people couldn't get in and out of Lecheng." At one point, progress in the pilot area was slow, but in August 2019, new motors started First, the authority was established Gu Gang, the former deputy mayor of Haikou, served as the director Gu Gang led the administration to fully cooperate with the provincial health and Health Commission, the drug administration and Haikou customs to reduce the waiting time of patients from 27 days to 6 months, to only 3-7 days, especially in a hurry, even on the same day In September 2019, the national development and Reform Commission, the health and Health Commission and the Drug Administration jointly issued the implementation plan to support the construction of the pilot area One of the biggest highlights is to allow the pilot area to pilot real world research On January 11, 2020, the medical and Drug Administration of Qianfeng district was officially unveiled This is the first regulatory agency jointly established by the health department and Drug Administration in China, and the integrated regulatory model of "health + drugs" was implemented The effect of acceleration is almost immediate Before the end of July 2019, Lecheng has created 14 "first cases in China" in two years, which means that patients first use a new medical device that has not been listed in China By January 11, 2020, the number will reach 51, and 37 will be added in five months, benefiting 253 patients In December 2019, the use of imported medical devices urgently needed in Lecheng pilot area was 21 times of the same period last year, and the number of users was 24 times of the same period last year Boao super hospital, which is chaired by Li Lanjuan, academician of Chinese Academy of engineering, has a total income of nearly 80 million yuan in 2019, while the monthly income in December is more than 12 million yuan, more than twice the average income in the previous 11 months At the beginning of the start-up of the pilot area, there was high expectation According to the development plan, the goal by 2024 is to achieve an industrial scale of more than 50 billion yuan Is it possible for Boao Lecheng, which has just entered the fast lane, to catch up with this goal in five years? If you have played the simulation city games and come to Boao Lecheng, you will have a feeling of starting a new game with a piece of land This 20 square kilometer land is located on the east coast of Hainan Island, under the jurisdiction of Qionghai City, 15 kilometers away from the permanent site of the Boao Forum for Asia annual meeting and 87 kilometers away from Haikou City △ in Lecheng Park, there are many medical institutions By Wu yeting There are many international medical institutions in this land At present, 9 medical institutions have been built and put into operation, 7 are under construction, and 5 have passed the review and entered the land acquisition process If it's not for the reminder of "Shangcun Street" and "Potou Street", when you are in the park, you won't realize that, a few years ago, it was just a common village In 2013, the State Council approved the establishment of Boao Lecheng International Medical Tourism pilot area in Hainan Land acquisition and demolition, investment attraction and the settlement and construction of medical institutions in the park were carried out in full swing At that time, Boao first age life care center, a health care institution that is now a major tax payer in the park, was the first group to enter In December 2015, the first age life maintenance center started construction and was completed in January 2017 In 2019, the total income of the first age is 417 million yuan, and the net profit is 40 million yuan The revenue accounts for 65% of the total income of the whole park Boao super hospital, which started operation in 2018, will be a little less In 2019, the total revenue will be 79.46 million yuan, 4331 outpatients will be received, 321 surgeries will be performed in the whole year, and 29 first cases will be completed in the whole year △ Boao super hospital lobby By Wu yeting The data of Lecheng didn't keep up with the plan According to the plan, "by 2019, the number of medical tourists coming to the pilot area will account for more than 5% of the total number of overnight tourists in the province, and the industrial added value will account for more than 10% of the total added value of the tourism industry in the province" If we take the tourism statistics of Hainan Province in October 2019 as an example, the number of overnight tourists is 6.3194 million, which is 5% of the planned number At least the number of visitors to the pilot area in the current month will reach 310000, but in fact, the number of visitors in 2019 is only 75000 In the game of Lecheng, many preferential policies are added Now to start acceleration, policies are also indispensable In addition to the previous "new drug special zone" and real world research policies, the latest one is the establishment of the medical and drug administration △ on January 11, 2020, the medical and Drug Administration of Boao Lecheng International Medical Tourism Pioneer Area in Hainan was unveiled By Wu yeting The administration bureau is a department level administrative organization jointly dispatched by the provincial health and Health Commission and the provincial drug administration to Lecheng pilot area The provincial health and Health Commission (department level) is the competent department, and the Provincial Drug Administration (deputy department level) is the business guidance department It is equipped with 15 administrative staff and 3 institutions, including comprehensive department, medical and health supervision department, and drug and medical device supervision department Before the establishment of the authority, the examination and approval time of medical devices had been reduced to 3-7 days What is the greater value of "two in one" of medical treatment and drugs? Gu Gang explained that before medical institutions came to the administration, sometimes they need to send people to accompany them to the provincial administration In the future, only major or high-level communication needs this, and other basic work can be solved in the park According to the publicity, the main responsibilities of the medical and drug administration are: Li Lijing, executive deputy director of Lecheng medical and drug administration, introduced to 8:00 Jianwen that the authority for clinical examination and approval of continuing to import medical devices lies in the Provincial Bureau In the future, some non first-time examination and approval of drugs may be gradually transferred to Lecheng At present, the work of Lecheng medical and Drug Administration focuses on supervision Li Lijing believes that the medical model in Lecheng is different from many traditional hospitals For example, Boao super hospital is called 1 + X, which is a platform, just like an airport, providing the most basic services, including the use of the latest drugs and devices in the world that have not yet been listed in China The hospital is just like an airline company, and the top teams can go to Lecheng to carry out their best medical treatment and services At this time, there may be problems that have not been encountered before, and the joint supervision of medicine will work more together The establishment of the authority is also conducive to solving new problems encountered in real world research The drug machinery that has not been listed in China will become part of the data in the real treatment process after being used in Lecheng If this product is listed in China in the future, it can be used as part of the supporting data, and the review speed and maturity will be very high For example, two or three years after the operation, there are three or five hundred cases, and it is found that it can support domestic listing When it is applied for registration, these patients are actually clinical experimenters The question then comes, "should these patients be charged?" At present, Li Lijing divides the real world research into two parts: retrospective and prospective Retrospectively, I just want to treat at the beginning After reaching a certain number of cases and finding that it can support registration, I will declare again This part is still studying whether to compensate patients again Forward looking is when medical devices enter Lecheng, the ultimate goal is to support the listing in the future This part is free However, there are a lot of ethical problems in free of charge, such as the treatment fee is free, but what about the transportation fee? In addition, real world research has a high demand for data Pure diagnosis and treatment is to collect some data according to the requirements of the hospital, but if we are going to do real world research, we must combine it with the future evaluation requirements of the drug audit center or the device audit center Otherwise, after completion, it is found that the data collection fails to meet the requirements of technical review, and it is impossible to supplement the data The development of real world research has a positive effect on the development of Lecheng Pioneer Area "In the past two months, 11 multinational pharmaceutical companies have signed strategic cooperation agreements with the pilot areas, which are mainly coming to the real world," said Gu Gang In the first half of this year, it is hoped that one or three varieties (based on real world evidence) will be approved, which is a milestone Once the products are approved, let alone in China, and in the real world applications, Lecheng is the leader According to a commanding point Boao Lecheng is the leading area in policy However, "policy alone, I don't think it will last long." Cai Jiangnan, executive director of Shanghai Chuangqi Health Development Research Institute, thinks that how to make patients and doctors maintain a certain amount of scale is a problem that needs to be considered in the Lecheng Pioneer Area The operation mode of the 1 + X shared hospital platform and the latest medical devices attracted the first batch of doctors and doctors brought the first batch of patients The "doctor airline" cooperated by Boao super hospital includes the team led by 17 academicians and experts, Shulan doctor group, Sinology doctor group composed of more than 20 experts, Hainan eye optometry Eye Hospital Co., Ltd., Hongji doctor group, etc Xu Wei, chief physician of cardiovascular department of Nanjing Gulou Hospital, is a member of Huashu doctor group It is Xu Wei's important work to bring the patients who have been received in Nanjing and can't be cured by the existing medical equipment to Boao Lecheng and treat them with the new medical equipment that has not been listed in China Over the past year, Xu Wei has flown from Nanjing to Hainan five or six times and completed several operations, including two "the first in China" One year ago, I followed Xu Wei to Hainan for the first operation of Micra TPS pacemaker implantation I visited Xu Wei in the hospital office two days ago to express my thanks again "The patient recovered soon after the operation and is now completely normal." Xu Wei still clearly remembered the patient's situation at that time - the patient had a bag and electrode infection after the implantation of the pacemaker Nanjing Gulou Hospital, as one of the only two centers for the removal of infected instruments in the country, helped the patient complete the removal operation After removal, the pacemaker must be implanted again, otherwise the patient will be in danger of life But the problem was that the patient had no good vascular access to allow doctors to re implant the traditional pacemaker The only way is to use a smaller lead-free pacemaker that was not yet available in China at that time Compared with the traditional pacemaker weighing up to 23g, this midtronic Micra TPS leadless pacemaker weighs only 2G, is 25.9mm long, and has a volume of 1.0 cubic cm It can be delivered through the femoral vein and implanted in the body, with little trauma Its advantage is also that it has no bag and electrode, which can reduce and