Biomedicine should not let innovation become "cauliflower"

Source: CPPCC News March 12, 2015 most developed countries in Europe and America regard biomedical industry as an important direction of national industrial development In China, it is also of great strategic significance and opportunity to vigorously develop the biomedical industry During this year's two sessions, the Central Committee of the rural labor party submitted a proposal on "deepening the reform of the health science and technology system to cultivate the health care and health service industry into a strategic highland of innovation driven development", in which it is proposed to list the biomedical and medical device industries as the emerging high-end manufacturing industries of the country For this reason, the reporter interviewed He Wei, member of the Standing Committee of the National Committee of the Chinese people's Political Consultative Conference, deputy secretary general and full-time vice chairman of the Central Committee of the agricultural labor party At present, it (Information Technology) and BT (Biotechnology) have become the consensus of many countries No matter in China or around the world, there is still a lot of room for our development Especially BT Reporter: in terms of output value, what is the current development situation of China's biomedical industry? He Wei: to talk about the development status of biomedical industry, we need to look at the international and domestic dimensions and the contribution rate of the industry According to the public data in 2013 (data in 2014 have not been released), the total global GDP is 73.98 trillion US dollars, of which the output value of the pharmaceutical industry is about 1 trillion US dollars, and the output value of medical devices is 340 billion US dollars, accounting for 1.81% of the global GDP In 2013, the output value (sales volume) of China's pharmaceutical industry is about 1 trillion yuan, the medical device is about 210 billion yuan, the GDP is 56.8 trillion yuan, the contribution rate of medicine and device in the whole economic structure is about 2.13%, which is close to the global proportion But if compared with the developed countries, our industrial scale gap is still obvious In developed countries, the output value of health industry (including service industry) accounts for about 15% ~ 20% of GDP, while in China, it only accounts for about 5%, at least 10% lower Obviously, there is still a lot of room for our development Reporter: as an industry known as "the fifth wave of wealth" after the IT industry, how far is the contribution rate of biomedical industry compared with IT industry? He Wei: Although BT and it have become the consensus of many countries at present, the contribution rate of biomedical industry (BT) to the economy is far from that of IT industry in both China and the world According to statistics, in 2013, the global IT industry only spent 3.4 trillion US dollars on production (input) There is no specific statistical data on output, but the proportion with input is generally 1:5 According to this ratio, we can roughly calculate the contribution rate of IT industry to GDP Therefore, in order to stabilize the position of China's biomedical strategic pillar industry and build China into the center of the world's medical science and technology, it is necessary for the government to strengthen the industrial support, enterprises to accelerate the pace of innovation and development, seize the opportunity and vigorously develop the biomedical industry Fortunately, China's biomedical industry has shown a steady growth in recent years Compared with the advanced countries in Europe and the United States, the biomedical basic research and clinical application level is shorter and the gap is smaller The ability and level of new drug development and prevention and control of major emerging infectious diseases have been significantly improved, and the scale and quality of biomedical manufacturing industry has also been significantly increased In fact, this is also the development trend of the world's biomedical industry Restricting the national medical security system and mechanism determines the level of industrial development Under the current medical security system in China, people only go to the hospital to see a doctor when they are ill, and only when they are treated in the hospital can they enjoy medical insurance reimbursement This passive state of medical treatment directly limits the development scale of the pharmaceutical industry Reporter: what are the main factors affecting the development of China's biomedical industry? He Wei: the fundamental factor is the national medical security system and service mechanism, which determines the development scale of the industry From a global perspective, there are three kinds of health care systems in different countries The first is a full coverage British system, in which all people are covered Under this system, hospitals across the country adopt unified pricing, and the government directly negotiates with pharmaceutical companies The second is the commercial insurance mechanism based on the United States The level of government insurance is very low Under this system, pharmaceutical companies work for insurance companies, the direction and price of drug research and development are all controlled by insurance companies, and insurance companies are controlled by several major chaebols, which is also the root cause of the failure of American medical reform The third system is a combination of national security and commercial insurance Under this system, the government is still the main body of medical insurance, but it will moderately develop part of commercial health insurance as a supplement People can buy a higher level of commercial health insurance in addition to the medical insurance provided by the government Our country is also this kind of security mechanism, but the level is low, the service ability of medical insurance and the participation of private capital are still weak, and the related industry scale is not large enough To solve this problem, we need to continue to deepen medical reform Under the current medical security system in our country, people only go to the hospital to see a doctor when they are ill, and only when they are prescribed and treated in the hospital can they enjoy medical insurance reimbursement This kind of state of passive medical treatment directly limits the scale of industrial development, because only products enter the hospital can have a market, and the market space of the hospital is limited The American pharmaceutical market is open As the largest pharmaceutical market in the world, people can also buy some generic drugs in Wal Mart Secondly, it is necessary to raise the awareness of the whole people about health We emphasize the Chinese dream, an important part of which should be the National Health dream, which requires us to improve the ability of national prevention and health care, break the original treatment centered system, so as to attract more elements to participate in industrial development Third, the strategy of industry going out Biopharmaceutical industry is a high-end manufacturing industry It is a common strategy of all countries in the world to actively promote the national high-end manufacturing industry to go global If one belt, one road, is the internal demand to stimulate the development of our bio pharmaceutical industry, the strategy of going out is external demand We can also make innovations in drugs and medical devices in China through the "one belt and one way" and high speed rail export policies and opportunities, and make joint efforts in the two markets of external demand and domestic demand to stimulate the development of the whole industry Fourth, technological innovation Biopharmaceutical industry is a monopoly industry with high threshold The strength of innovation ability directly determines the future of industrial development Of course, technological innovation needs atmosphere, and our government departments need to provide enterprises with a market environment for innovation The direction should attach importance to the original innovation of enterprises Facts have proved that major scientific and technological achievements are often the result of unintentional planting of willows and willows At the beginning of the research, the problems or fields involved in these achievements are often ignored, non mainstream and marginal Reporter: at present, what is the overall innovation capability of China's biomedical industry? He Wei: Generally speaking, the lack of innovation ability, especially the lack of original innovation ability, is an important problem faced by China's biomedical industry In order to solve this problem, we need to increase the research on the pathogenesis of the disease and make scientific problems clear For example, we should strengthen the reform of the science and technology system of the Chinese Academy of Medical Sciences, form a dual wing structure of national task-based scientific research institutions and discipline based personnel training in Colleges and universities, establish a national major task-oriented medical technology research and development base, form an open, mobile and competitive situation, and give special support to the institutions undertaking the tasks of directive national key research and development plans Colleges and universities mainly cultivate innovative talents and organize them to carry out research on knowledge and technology innovation At the same time, we should broaden the points and areas of original innovation, not only focusing on one aspect or field Facts have proved that major scientific and technological achievements are often the result of unintentional planting of willows and willows At the beginning of the research, the problems or fields involved in these achievements are often unpopular, even non mainstream and marginal Therefore, in the field of basic research of original innovation, government intervention should be reduced as much as possible so that scientists can do it autonomously In the R & D process of enterprises, government departments should put forward some important directions, and make use of market mechanism as much as possible When making policy, one should combine one belt, one road, one region, one region, one region, one region, one side, one way, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side, one side Reporter: specifically, how should the government support the scientific and technological innovation of biomedical enterprises? He Wei: we should strengthen the policy protection of innovative products If a country wants to become an innovative country, it can't let innovators suffer losses It needs to give them enough support and respect, and the protection of intellectual property rights of the innovative products it develops runs through the links of R & D, production, approval and sales At present, China's current situation is that it has made great success in talent introduction, but the protection of innovative products is not enough It is also a biomedical enterprise in Yizhuang Some of its products are supported by national major special projects, which can replace imported products in clinical practice However, its products encounter many obstacles when entering the market, mainly in two aspects: first, there are different fees for clinical testing projects in different regions, such as Beijing, whose medical fee standard is 1999 In, not only the project is not complete, but also the charging standard sets the use of domestic reagents as half of the imported products If the hospital purchases domestic products, its income will be greatly reduced Therefore, it is generally preferred to import products, which is very unfavorable for the domestic products to enter the market At the same time, because it is a new product, it is necessary to enter the clinical test catalog first, and then declare the price through the local authority in various places (provinces and cities), which is also a very long process Second, the national approval process should be accelerated At present, a new drug in China has to enter the clinical trial stage The waiting time for approval in relevant departments is about 2 years, and some of them have not been approved for 2 years In countries with drug filing systems, such as the United States, the waiting time for new drugs to enter the clinic is only one month Therefore, it is suggested to speed up the revision of the drug administration law of the people's Republic of China, change the examination and approval system into the filing system, and speed up the entry of innovative drugs, medical devices, materials and preparations into clinical trials Third, support should be given during the period of drug listing Such as supporting the application and promotion of the first set of domestic medical device innovation equipment We will focus on supporting the development and growth of small and medium-sized technology R & D enterprises, encouraging the establishment of green channels for the second and third board listing of biomedical innovation enterprises, and fast channels for the entry of pharmaceutical technology innovation products into the medical insurance catalog For the support of innovative product listing, the role of the government should mainly focus on the early stage, that is to encourage source innovation For example, increase support for basic biomedical research For the enterprises that have already landed on the first board, there is no need to support them At this stage, the financial investment of enterprises should mainly rely on financial innovation and reform, so that venture capital and stock market can play a greater role Fourth, we need to formulate strong industrial policies In industrial policy, we should