Domestic medical device innovation has always been concerned by members of the National Committee of the Chinese People's Political Consultative Conference. The “National Medical Device Innovation Needs Atmosphere” manuscript published by the newspaper in August 2013 was highly valued by the central leadership and was transferred to the State Food and Drug Administration, which played a role in promoting the publication of relevant documents. On this topic, many members are asking: Our "嫦娥" can go to heaven, "蛟龙" can go to the sea, why are there no brand of our medical equipment? I really hope that domestic medical device innovation can have a "defective project."
More than 90% of the high-end market is monopolized by foreign countries
Hu Shengshou, a member of the National Committee of the Chinese People's Political Consultative Conference and the director of the Fuwai Cardiovascular Hospital, said that the output value of the life-medical science-related industries in the United States accounts for more than one-third of the total GDP. The proportion of China is still small. “Although the market for medical devices is large, the level of innovation is not high, especially for high-end medical devices.”
More typical is the oral implant. Yu Guangyan, a member of the National Committee of the Chinese People's Political Consultative Conference and the former dean of the Peking University Stomatological Hospital, said that the dosage of implants in the dental implant department is relatively large, but most of them must be imported, and the price should be about 15,000 yuan. Once, a central leader came to see the teeth and suggested that the Shenyang Aircraft Factory be used to build implants. “I told the leader at the time that our design was fine, but there was still a gap between the production process and foreign countries. Until now, this problem has not been solved.”
The same is true for pacemakers. Zhang Wei, a member of the National Committee of the Chinese People's Political Consultative Conference and the director of the Arrhythmia Diagnosis and Treatment Center of the Fuwai Cardiovascular Hospital, said that it takes a total of 70,000 yuan to implant a cardiac pacemaker for patients. The patient feels very expensive. In fact, nearly 80% of the cost of imported medical equipment. A lot of our money has been earned by foreign companies.
In the domestic medical device market, the market share of cardiac stents is the highest. Huo Yong, member of the National Committee of the Chinese People's Political Consultative Conference and director of the Department of Cardiology of Peking University First Hospital, introduced nearly 700,000 stents in China in 2013, of which about 78% were made in China. "But we are still based on imitation, and the original and original intellectual property rights are in the hands of others."
"Domestic medical device innovation is related to the people's health level. The intellectual property rights of so many devices are in the hands of others, so I don't have to give you the final say. From this perspective, this also involves the national strategy." Zhao Guangyu, deputy chairman of the Zijin Zhejiang Provincial Committee, said.
Medical staff involved in research and development lacking motivation
“Medical device innovation comes mainly from doctors. Enterprises may also have good ideas, but because they are not in clinical practice, it is impossible to fully understand the needs of disease diagnosis and treatment, so the demand for equipment and the shortcomings are not as clear as doctors.” Huo Yong believes that we should learn from Israel. In Israel, many new medical devices come from the creativity of clinicians. The state encourages clinicians to participate in the research and development of medical devices from the policy, giving doctors a generous return.
We are far from supporting doctors' participation in medical device research and development. One is that the role of doctors participating in the role is unclear, and the identification of intellectual property rights is also problematic. "Doctors are unit people. With results, most of the returns are returned to the state or the unit. How can they mobilize their enthusiasm?" Hu Shengshou said that their hospitals have introduced regulations that doctors participate in medical device innovation, and 80% of the rewards belong to the doctor himself. But what about the country? Should there be a policy in this area?
“The awareness of close integration between enterprises and clinicians is also relatively weak.” Yu Guangyan said that many companies often find a doctor after they have formed a clinical trial. Once they are not suitable for clinical use, they must be overhauled, and some may even be completely Overthrowing not only delayed the research and development process, but also wasted a lot of manpower, material resources and financial resources. “Actually, starting with the idea, the company should let the doctors participate deeply, participate in the whole process, and take less detours.”
Poor approval and severe control of innovation ability
"A new medical device is spent 50% or even 80% of its time from research and development to listing. Some of them are for a few years. The technology leader has also been caught up by others. How to encourage innovation?" Hu Shengshou said. Although the State Food and Drug Administration issued the "Special Approval Process for Innovative Medical Devices (Trial)" in February last year, from the practical point of view, there are still many problems in our approval. Some problems are due to the lack of professional competence in the approval department and the lack of professionalism of the approving staff.
To give a simple example, a heart stent can be used for in vitro and in vivo clinical trials. We don't even have a national testing base. It is impossible to build a multi-base throughout the country. Can you authorize a large-scale top three hospital to do this?
The data of Chi Hui, a member of the National Committee of the Chinese People's Political Consultative Conference and the deputy director of the Information Research Institute of the Chinese Academy of Medical Sciences, can explain the difficulties faced by China's medical device approval and supervision. At the end of 2012, there were 15,348 medical device manufacturers and 185,575 enterprises in operation, and there were 2,459 medical device production supervisors, 966 full-time employees, 3,683 supervisors, and 1,158 full-time employees. The management supervisors shall undertake the supervision tasks of 27 production enterprises/160 operating enterprises.
It is also known that there are currently only 103 staff responsible for medical device registration in the country, and there are about 200 medical device technical reviewers from the provincial bureaus and the State Food and Drug Administration. Among them, the technical reviewers of the Medical Device Technical Evaluation Center of the State Administration of Taxation With only 60 people, it is far from the need to effectively complete the basic tasks.
"In recent years, the State Food and Drug Administration has increased the training of professional talents, but this has a process, because these people must be compound talents, both to understand sound and optoelectronics, biology, medicine, chemistry, materials science, etc. Multi-faceted knowledge, but also familiar with this set of approval procedures." Chi Hui said.
Unreasonable bidding pricing makes companies lack innovation enthusiasm
"Medical devices are not the same as other products, not the lower the better, the price is too low, the company is not profitable, the quality is difficult to guarantee." Zhao Guangyu said that there are some problems in our bidding pricing policy, such as CPI is rising, manpower The cost is also rising, and the bidding price can not be adjusted for several years. There is also a low-price policy. The original products listed first are priced lower than the follow-up products listed after the listing; the new products from other provinces and cities can set a new price. However, the original product bidding price of this province and city does not move.
"There are also problems of different prices for domestic and foreign products. This situation is more obvious in cardiac stents." Huo Yong said that there is almost no difference in quality between domestic and imported cardiac stents, but the price of imported products is The price is almost twice that of domestically produced products. "Considering tariff issues, imported products can be appropriately higher, but there should not be such a big gap."
In terms of tax burden, the preferential treatment of domestic medical device companies is also limited. Zhang Wei pointed out that the current state implementation of high-tech enterprises is a three-year tax exemption policy, but medical device research and development has the characteristics of “high investment, long cycle, and high risk”. Some R&D needs three years and five years, even ten years and eight years. What should I do? He proposed to extend the tax exemption period for domestic medical device enterprises; the state levies taxes on domestic medical device enterprises at a rate of 4% of bio-products enterprises, and at the same time optimizes the ecology of the industrial chain, so that innovation can “profit” and make national brands “stay up” .
Set up a special fund to carry out key areas to tackle problems
"China's economic downturn is relatively strong, and it is important to cultivate new economic growth points. The life medical science represented by medical devices is definitely a new economic growth point." Hu Shengshou believes that in the context of national implementation of innovation-driven projects, It is especially important to improve the level of innovation in domestic medical devices, which should be raised to the national strategy.
At the national level, Hu Shengshou believes that it is necessary to follow the “嫦娥 project” and support domestic medical device innovation through major special funds, and to continuously and steadily invest. “Pay special attention to the waste of research funding, and don’t spend all of your money on low-level reproduction.”
"You can select some key areas, and support major enterprises, medical personnel, scientific research units and other joint research through major special funds, and strive for breakthroughs." Zhang Wei suggested.
Chi Hui introduced that in fact, in the major projects of the strategic emerging industries established by the National Development and Reform Commission and the Ministry of Industry and Information Technology last year, there were major projects of high-end medical equipment. "We have a weak foundation in medical device innovation and a late start. There are still many needs to be perfected in terms of industrial base, production technology, professional talents and national policies. We cannot do this because we have to catch up with others. Historical patience.