Editor's note: Innovation drives change, and medical innovation and transformation have formed a wave. According to the statistics of Guanyan Tianxia, in 2020, the authorized patents of the top three hospitals in China increased by 76% year-on-year.
As Song Chunli, vice president of the Third Hospital of Peking University, said, "The hospital has rich disease resources and practical needs that scientific research institutes and enterprises do not have, and the 'Spring River Plumbing Duck Prophet', the difficulties and problems encountered in medical treatment, are all major demand traction for scientific and technological innovation." Hospitals should be more active places than the innovation factor of universities, and now is the golden age."
What a "golden age"! The ecology of doctors and medical institutions under this wave is the focus of our attention. At present, the transformation of medical innovation has entered no man's land in terms of institutional design, organizational structure and cooperation model, and a new innovation and transformation framework is urgently needed.
In view of this, the health industry and the China Medical Innovation Alliance have specially planned to launch special reports to focus on the pain points in the medical innovation transformation chain and promote the continuous progress of all parties in terms of interest linkage, industry self-discipline, and regulatory innovation.
Source: Health Community
Author: Shen Mengxia
The attitude of public hospitals toward doctors to start a business has changed in recent years.
From 2015 to 2016, with the revision of legal provisions at the national level, the formulation of supporting rules to the deployment of specific tasks, the "trilogy" of promoting the transformation of scientific and technological achievements was played, and a series of policies to support the transformation of medical innovation achievements were introduced, so that doctors' innovation and entrepreneurship received the "four-level linkage" support of "national, ministerial, local and medical institutions".
However, even today, within hospitals, there is still a discussion about "doctor entrepreneurship".
This discussion can be divided into two cases, one ethical and one technical. The former focuses on the issue of "conflict of interest between doctors' prescription rights and income rights", while the latter involves the practical issue of "how to buy shares at a price".
In the face of doubt,
What about the doctor's right to prescribe vs the right to earn?
"Suppose an internist invents a new drug and obtains a stake in a new drug company with this patent, and after the drug is approved for marketing, the doctor often uses the drug to treat patients instead of other brands, is there 'unfair competition'?" In an exclusive interview with the health community, Song Chunli, vice president of peking university third hospital, expressed his concerns and doubts about doctors starting a business.
In fact, this is a question that the medical community has never stopped exploring - society requires doctors to make well-founded, uninterested professional judgments, and when there is a conflict of interest, how should doctors face questions from the public?
Song Chunli said that the doctor's duty is to treat diseases and save people, and the original intention of doctors to invent and create is also to better solve the problems in clinical diagnosis and treatment, benefit the people, rather than to pursue interests, "Many doctors will say when the results are transferred and transformed, as long as they are used in the clinic as soon as possible, it is good to solve the problem."
Song Chunli, Vice President of peking university third hospital
In fact, the existence of conflicts of interest does not mean that the judgment of interest subjects must be affected.
Wang Yue, a professor at peking university's Department of Medical Ethics and Law, told the health community that in this case, the key to determining whether there is "unfair competition" lies in whether there is commercial bribery, and the key to whether commercial bribery is established or not is "whether the buyer or seller has more opportunities to deal in the sale and purchase of goods and services."
Wang Yue, Professor of Medical Ethics and Law, Peking University
"If there is evidence that there are better drugs to choose from, but the doctor does not choose, but chooses the products produced by his own company, this may constitute commercial bribery." Wang Yue said.
But at the same time, Wang Yue also stressed that if the drug is through fair competition, such as entering the hospital through collective procurement, then it is "far-fetched" to be identified as a commercial bribe.
In Wang Yue's view, doctors in public hospitals should be supported and encouraged to participate in the company's equity setting at the price of their own intellectual property rights, after all, China's existing policies and measures can basically protect the rights and interests of patients from being affected.
"After the centralized procurement of drugs, the impact of doctors' prescription rights is 'limited', but the collection should be staged. Looking to the future, after the inflated drug prices are reduced, the medical insurance policy is adjusted, and the incentive mechanism for controlling the cost of medical institutions is established, the right to purchase drugs should be returned to medical institutions, because the actual differences in drug procurement of different medical institutions are still relatively large." Wang Yue said that this requires strict attention to the hospital's administrative authority, such as the director of the clinical department, the director of the pharmacy department, and the members of the hospital's leadership team.
"The best preservatives are 'transparent' and 'sunny.'" Wang Yue suggested that public hospitals should explore the establishment of a property declaration system, requiring personnel with administrative responsibilities to truthfully declare their assets and income and disclose them within the organization.
From Cash Rewards to Equity Awards: How to Buy Shares?
In 2016, the former National Health and Family Planning Commission, the Ministry of Science and Technology and other five ministries and commissions jointly issued the "Guiding Opinions on Strengthening the Transfer and Transformation of Health and Health Science and Technology Achievements", requiring medical and health institutions and other relevant units to study and formulate rewards and income distribution methods for the transfer and transformation of scientific and technological achievements, improve the service invention system, and give rewards to those who have completed job scientific and technological achievements and other personnel who have made important contributions to the transformation of achievements, in accordance with the following provisions:
1. Where job scientific and technological achievements are transformed by way of technology transfer or licensing, a proportion of not less than 50% of the net income obtained from technology transfer or licensing shall be used for rewards;
2. Where scientific and technological achievements are invested at the price of investment and transformation, a proportion of not less than 50% shall be extracted from the shares or capital contribution ratio obtained at the price investment for rewards;
3. Personnel who have made major contributions in research and development and the transformation of scientific and technological achievements shall receive no less than 50% of the total amount of awards.
After the document was issued, the Third Hospital of Peking University, the West China Hospital of Sichuan University, the Fuwai Hospital of the Chinese Academy of Medical Sciences, and the Xiangya Hospital of Central South University have introduced in-hospital results management measures, stipulating that the proportion of rewards for project teams is more than 80%, including cash awards and equity awards.
However, most hospitals still dare not transfer scientific and technological achievements in the form of "buying shares at a price".
"According to the regulations, hospitals cannot hold shares, and hospitals do not dare to delegate the right to give scientific researchers to hold shares on behalf of researchers, because it involves a series of problems such as the loss of state-owned assets." Guo Hua, director of the scientific research department of Xiangya Hospital of Central South University, said in an exclusive interview with the health community.
Guo Hua, director of the scientific research department of Xiangya Hospital of Central South University
According to Guo Hua, there are currently three main ways to transform scientific and technological achievements in public hospitals:
1. Transfer the scientific and technological achievements to others;
2. Licensing others to use scientific and technological achievements;
3. Invest in the scientific and technological achievements at a price, and convert the shares or capital contribution ratio.
"The first two are very easy to operate, only the 'price into the shares' is not easy to achieve." Guo Hua said that during the "13th Five-Year Plan" period, the contract amount of Xiangya Hospital for the transformation of scientific and technological achievements was close to 300 million yuan, and none of the projects adopted the method of 'buying shares at a price'.
Song Chunli also revealed to the health community that as of now, the Third Hospital of Peking University has transferred 146 items, with an agreement amount of nearly 200 million yuan, all of which are converted in the form of non-equity income transferred or licensed.
"From the perspective of protecting scientific and technological innovation, compared with the one-time transfer of transformation results, of course, it is better (researchers) to set up their own companies, and it is more delicate and long-term." Song Chunli said that it is only now that the "hard" policy is allowed, but the "soft" policy has not yet been allowed.
However, there are also hospitals that take a different path.
In February 2018, the National Health Commission asked West China Hospital as a pilot unit to undertake the exploration task of "in-hospital policy system for the transfer and transformation of scientific and technological achievements". Taking this as an opportunity, West China Hospital promulgated the Nine Achievement Transformation Policy (hereinafter referred to as "West China Nine Articles") in May of the same year.
The first article in the "Nine Articles of West China" stipulates that the person who completes the achievement and the hospital are allowed to agree in advance on the ownership or equity ratio of the scientific and technological achievements of the job. Before applying for a patent or making a value for investment in patented technological achievements, the person who completes the results may agree in advance with the hospital on the ownership or equity ratio of the scientific and technological achievements in the form of an agreement, and allow the person who completes the results to occupy the shares in his or her personal name.
Yuan Shulan, director of the Transformation Department of the West China Hospital of Sichuan University, introduced to the health community that in order to achieve the transformation of the results of the "price investment", the person who completes the results needs to submit an application to the Ministry of Achievement Transformation, and the Ministry of Achievement Transformation organizes a meeting of the Achievement Transformation Working Committee to discuss and resolve the application projects and form the "Meeting Minutes"; then the Transformation Department organizes the project docking meeting, formulates the "Agreement on The Reward agreement for the investment of scientific and technological achievements for investment and equity", and submits it to the joint party and government of the hospital for discussion and the formation of a meeting resolution. If you pass, you can go through the transfer conversion procedures.
Yuan Shulan, Director of the Transformation Department of West China Hospital of Sichuan University
"It must be a major scientific and technological innovation achievement before it can be requested to convene a meeting of the Working Committee on the Transformation of Achievements." Yuan Shulan said that the Achievement Transformation Department and the State-owned Asset Management Department of West China Hospital will conduct a basic assessment of the innovation results in advance and solicit expert opinions. If it is a general innovation or difficult to transform or the market space is not large, it is usually not invested in the way of conversion.
In September 2020, as the first batch of "price investment" projects in West China Hospital, 21 scientific and technological achievements such as "new crown virus pneumonia vaccine" were transformed. Huaxi Hospital contributed 511.6 million yuan in the results, accounting for 64.76% of the shares of the newly established company. Among them, Wei Yu, the completer of the hospital award achievement, has 51.808% of the equity of the whole team, and the West China Hospital Asset Company of Sichuan University accounts for 12.952% of the shares. At present, the newly established company has completed the third round of financing, with a valuation of 10 billion yuan and a total market financing of 2.7 billion yuan.
In addition, Fuwai Hospital also revised the "Administrative Measures for the Transformation of Scientific and Technological Achievements of Fuwai Hospital" formulated in 2017 in early 2021. According to the new version, the person who completes the results or the investor may pay the hospital an equal amount of money to the hospital to purchase the shares of the newly established company that the hospital should hold in the future, and the hospital will transfer the equity of the new company that should be held in the future to the person who completed the results or the investor.
"In this way, first of all, there is no loss of state-owned assets; secondly, in terms of operational feasibility, it is more grounded and grounded." Ouyang Chenxi, deputy director of the Achievement Transformation Center of Fuwai Hospital of the Chinese Academy of Medical Sciences, said that compared with the original version, the new version of the program is more practical.
Ouyang Chenxi, deputy director of the Achievement Transformation Center of Fuwai Hospital, Chinese Academy of Medical Sciences
In fact, not only are hospitals exploring the establishment of a better model for the transformation of scientific and technological achievements, but the country is also exploring, and the policy side continues to "increase".
In May 2020, the Ministry of Science and Technology and other 9 departments issued the "Pilot Implementation Plan for Granting Scientific and Technological Achievements ownership or long-term use rights to scientific and technological achievements"; in October 2020, 40 pilot units determined that Beijing Jishuitan Hospital and Peking Union Medical College of the Chinese Academy of Medical Sciences were included in the pilot.
"Most hospitals do not have their own shareholding platforms, and there are no wholly-owned companies specially set up to transform the results, so from an operational point of view, the channel for buying shares at a price is not yet completely smooth." However, after empowering researchers, we can open up the transformation path of "hospitals do not own shares, scientific research teams account for shares". Yu Yang, director of the scientific research department of Beijing Jishuitan Hospital, told the health community that "empowerment" has solved the obstacle to the landing of investment in scientific and technological achievements in hospitals and expanded the model choice of transformation of scientific researchers' achievements.
Yu Yang, Director of the Scientific Research Department of Beijing Jishuitan Hospital
In 2021, Beijing Jishuitan Hospital gave Zhang Haohua, deputy chief physician of the Department of Orthopedics, ownership of the scientific and technological achievement "Mobile Intelligent Motion Monitoring Orthopedic Rehabilitation Guide", becoming the first successful case of empowerment in Beijing. According to the empowerment agreement, Beijing Jishuitan Hospital and Zhang Haohua will be the co-owners of the results of the position, and the subsequent transformation benefits of the results will be distributed according to 30%:70%.
Which medical innovations can be translated?
Not all medical innovations can be translated.
According to statistics, during the 12th and 13th Five-Year Plan periods of Beijing Top 3 Hospital, a total of 145 Chinese patents were transferred, accounting for 1.65% of the total number of patent applications in 10 years. Among them, there are 104 invention patents (accounting for 72% of the total transfer volume), 37 utility model patents and 4 design patents.
"Most medical institutions have a low threshold for innovation and a low probability of conversion." Zhang Ning, executive secretary of the China Medical Innovation Alliance and general manager of Beijing Kangwei Medical Innovation Technology Co., Ltd., said that although the state and medical institutions have been increasing their investment in medical research and the reserves of medical innovation achievements have been continuously enriched, most of the patents do not have transformational value.
For example, a diagnostic reagent invented by a hospital, the genotyping kit for children's acute leukemia, although it has great clinical value, the market scale it points to is small and not enough to support the cost of transformation cooperation, so it has not been able to achieve transformation.
Yu Yang also said: "The most critical issue in the transformation chain is whether the quality and level of innovation results are high enough."
So, which medical innovations are suitable for translation?
According to Zhang Ning, the current types of transformation of China's medical innovation achievements can be roughly divided into 7 types:
1. Small innovations that grasp clinical pain points;
2. Overall solution of the department;
3. Data + Artificial Intelligence Project;
4. Pharmaceutical projects;
5. Kit items;
6. Consumables items;
7. Interdisciplinary learning innovation projects.
Among them, type one - small innovation is difficult to form a high technical barrier, easy to be imitated and replaced, mainly relying on hospital visibility and clinical use for transfer; type seven - multidisciplinary interdisciplinary projects, is the main development direction of future medical research.
In fact, many important medical concepts in history have involved the intersection of various disciplines of life medicine and engineering science, such as blood pressure, blood flow, bone density, bone strength, etc.
The combination of medicine and engineering has been explored by scholars for decades. Since the 1970s, the world's top research universities such as Harvard University, Stanford University, and Princeton University have realized the importance of "medical and engineering intersection" and have successively established interdisciplinary research institutes or research centers to carry out research on the combination of medical and engineering disciplines.
China established the Shanghai Medical Device College in the 1960s, but did not have a biomedical engineering program until after 2000. Overall, China's medical and engineering disciplines have been separated for a long time, and there is a shortage of cross-compound talents in medical and engineering.
"After our students enter the school, they learn mostly about how to cure diseases and save people, and rarely learn to invent and create." Song Chunli said that in the long run, for medical innovation, the talent problem is still a pain point problem.
But Song Chunli also said that the duty of clinicians is to treat diseases and save people, inquire about evidence, treat patients in accordance with guidelines and norms, and require clinicians to innovate, in fact, to some extent, it exceeds the duty requirements of everyone for medical workers.
"Therefore, there is a reference to 'exert the spillover effect of high-quality medical resources', that is, to put forward higher expectations for capable and qualified hospitals and doctors, and to be able to exert their wisdom and wisdom in the daily heavy diagnosis and treatment work, to explore and carry out technological research and development on clinical issues, in the existing guidelines, norms, and even the science that current technical products cannot reach, so as to form an effective weapon for the treatment of diseases and promote their application."
Therefore, Song Chunli stressed that it is very necessary to empower doctors. In 2019, the Third Hospital of Peking University established the Institute of Medical Innovation and led the establishment of the "Beijing Xueyuan Road Clinical Medicine Collaborative Innovation Alliance", with the purpose of building a platform for the transformation and cross-cooperation of clinical research scientific and technological achievements.
Beijing Xueyuan Road brings together Peking University, Tsinghua University, Chinese Academy of Sciences, Beihang University, Beijing University of Posts and Telecommunications, Beijing Forestry University and many other universities and research institutes.
"This platform is like an aircraft carrier, it is a fighter group, all kinds of fighters can land on the aircraft carrier, and research in various disciplines can also be done with this platform." Song Chunli said.
Unlike Peking University Third Hospital, which has been involved in collaborative innovation in recent years, the history of medical-engineering cooperation in Beijing Jishuitan Hospital has a long history and has become a tradition.
"Beijing Jishuitan Hospital is a tertiary hospital with orthopedics and burns as its dominant disciplines, and its specialty characteristics determine that there is more demand for innovation in medical devices." Yu Yang said that since 2004, when the hospital promoted the research and development project of orthopedic surgical robots, it had already begun to explore the combination of medical and engineering.
At present, Beijing Jishuitan Hospital has successfully transformed 6 achievements, and has established a number of medical and industrial enterprise R&D teams in the fields of 3D printing technology, artificial intelligence assisted diagnosis, and orthopedic high-value consumables. In addition, the hospital as the leading research and development of intelligent orthopedic surgical robots has been widely used in clinical practice, as of June 2021, has completed more than 15,000 operations in more than 120 medical institutions across the country.
Although there are successful cases of the above hospitals, looking at the whole country, we have to admit that China's medical innovation and achievement transformation do not match China's medical research strength.
Why have so many papers been published and so many patents obtained, and The level of device and drug research and development in China is still not high?
From the state to the hospital, why does the huge investment in scientific research not produce much practical benefit?
Why do some public hospitals even if they set up a special transformation management department, but most of them work part-time for other departments?
Please take a look at the second content we are pushing at the same time today, "Why are Chinese hospitals short of talents in this regard?" 》
Source | The health community
Written by | Shen Mengxia