Experts: Cancel the Super National Treatment of Imported Instruments

“In the past, imported artificial knee joints were more than 50,000 yuan each, and coronary artery stents were more than 40,000 yuan each. With domestic products, they respectively cut prices to 30,000 yuan and over 20,000 yuan. In the field of medical devices, there has been domestic For intellectual property products, the price of imported products is often reduced to about half of the previous price."

Why Encourage Domestic Originality “With domestic intellectual property rights, the price of imported products can be reduced by nearly half”

At present, in the Chinese medical device market, what percentage of China's creativity can be occupied? Fan Yubo, dean of the Yangtze River Scholar and Beihang Institute of Biology and Medical Engineering, introduced three levels:

In terms of low-end products, such as medical consumables and disposable medical products (syringes, infusion tubes, infusion bags, etc.), domestically produced products dominate the market, and product quality can be basically guaranteed, and foreign exchange can be earned through exports. The technical content of these products is relatively low, and there are basically no intellectual property issues.

In the low-end areas, such as ultrasound systems, monitors, and X-ray machines that are relatively low-end in terms of performance and specifications, the competition between domestic and imported products is fierce. This one, domestically produced can account for about 50%, and the quality is not much different from that of foreign countries, but it is facing increasing pressure from foreign famous brand companies and even acquisitions.

In the mid-to-high-end sector, imported products dominate the market, and the overall level is over 90%. More importantly, the core technologies or components of such products are often monopolized by foreign companies. Domestic enterprises mostly import core processing technologies, materials and even components. System integration and assembly in the country have lower profitability.

Fan Yubo introduced that if the quality of 60 points is qualified, our high-end products, our products within 70 points, some of the outstanding can reach more than 80 points, while the basic products can be more than 90 points.

Since the quality of imported high-end medical devices is better than that of domestic ones, why should we innovate independently instead of buying imported products directly? Fan Yubo said that only through high-quality domestic self-owned brand products competing with imported products, the market price of medical devices will decline, so that the people will truly benefit. If most products are imported or imported brands are used, the country will face a huge economic burden.

"In the past, artificial knees had to be imported for more than 50,000 yuan, and coronary stents were for more than 40,000 yuan. After they made domestic products, they reduced their prices to 30,000 yuan and 20,000 yuan respectively." Fan Yubo said, "In medical devices There are many examples of such fields. With domestic intellectual property products, the prices of imported products tend to drop to about half of what they used to be."

In China, the ratio of sales of medical devices and medicines is 1:3. In developed countries, the ratio of sales of medical devices and medicines is close to 1:1. Fan Yubo believes that in China's primary hospitals, more serious drug abuse and underutilization of advanced medical devices also exist. If you can make up for the shortcomings of medical devices, many diseases can be prevented at the grassroots level, early diagnosis, early intervention, and reasonable treatment, the overall medical cost will also decline, and it will be more conducive to the health of the people.

Opportunities for Fair Competition for Domestic Brands "R & D of similar products, state-owned enterprises should spend 2 to 3 years and invest millions more."

Recently, the "Regulations on the Supervision and Management of Medical Devices" promulgated by the State Council proposed that the State encourage the research and innovation of medical devices. Fan Yubo believes that encouraging innovation requires detailed policies and assistance. It is necessary to vigorously develop basic research and transformation research related to medical devices. At present, there are several tasks that need to be started immediately:

Optimize the current bidding system. In the current provincial tendering regulations, medical devices are classified according to domestic and import requirements, and group bidding is conducted. Imported products enjoy higher pricing. Fan Yubo said, "Products of the same grade and performance, imported products are priced higher, have more added value, and naturally have the money to open up and occupy a larger market. Many domestic manufacturers are complaining that imported products enjoy 'super national treatment'. 'Similar unreasonable treatment should be abolished, giving domestic brands the opportunity to compete fairly.'

Policy support needs to be strengthened. Under the current policy, some implanted medical devices are often classified as Class II products in the United States. They can obtain US or European marketing approval without clinical trials. When these products enter China, they do not need to conduct clinical trials according to current Chinese policies. , imported products can save a lot of time and cost.

However, similar products in our country tend to be classified into three types of products. Domestically produced enterprises need to spend 2-3 years, millions of dollars or even more expenses to make a product into the clinic. Over time, the gap between domestic companies and foreign companies will only increase.

Unfair competition should be standardized. On the one hand, a large number of importers sponsor doctor training and participate in international and domestic academic conferences. “A meeting in a clinical field often involves tens of thousands of doctors. Most of the funds are sponsored by foreign companies.” Fan Yubo said that a large number of international brand opinion leaders occupy the meeting. The forum, discussion and introduction are all imported products. Over time, doctors will prefer importers and are accustomed to using imported products. On the other hand, various types of research funds and clinical training funds in our country support a large number of young and middle-aged doctors to study in developed countries in Europe and America. Most of the contacts and use during the study period are products of foreign companies. To a certain extent, they have done free training for foreign companies. .

At the same time, importers have maliciously reduced their prices and competition for small-scale, low-threat domestic self-innovative companies, squeezing their space for survival and development. For domestically-developed innovative brands that have already formed a certain scale, foreign companies often make huge purchases and then let them slowly withdraw from the market. Once there is no domestic product to compete with, imported products will monopolize the market, resulting in price monopoly.

Fan Yubo believes that if this type of situation is not corrected, it will be the National Medical Insurance Fund and the patient itself if they pay for high-priced medical devices and similar training or meetings.

Supervision and refinement, do not have a ruler in the end, "If the rice cooker is a medical device, you can sell more than 10,000 yuan, a manufacturer can not lose money."

The development of medical devices involves all aspects. Fan Yubo said that we are a latecomer country and there are many lessons to be added:

Pay attention to medical devices as important as medicines. Since the founding of New China, our pharmaceutical industry has been very complete, from the Food and Drug Administration to the National Research Institute, to the National Prescription Pharmaceutical Factory, and a large number of medical schools. Nowadays, compared with more than 1,000 undergraduate and specialist drug-related majors in the country, the biomedical engineering specialty was only available after the 1980s. Now it is only over 100. Medical devices are a multidisciplinary and high-knowledge sedimentation technology area and should increase investment.

There must be more professional and detailed supervision. Relatively speaking, there is still a large gap between the size and level of the medical device supervision team. It should also be accelerated. It should recruit more personnel who are directly related to biomedical engineering. Now, like products such as electronic blood pressure meters, the relevant departments, like pharmaceutical products, require a large number of clinical trials to register. In fact, this is completely unnecessary. It only pushes up the cycle and cost of domestic R&D.

Fan Yubo joked, "The danger of an electronic blood pressure meter is actually worse than that of a rice cooker. If a rice cooker is a medical device, it may cost more than 10,000 yuan, and manufacturers may not lose money."

The chain of innovation and research and development requires further support from the country. Fan Yubo said, “Since the 'Twelfth Five-Year Plan' period, relevant departments of the Ministry of Science and Technology, the National Development and Reform Commission and other countries have increased their attention and support, but the degree of emphasis is still insufficient. The field of medical device technology has not yet been included in the national major special projects.” In China, from the basic From research and transformation studies to applied research, the entire innovation chain is still weak and incomplete. In the United States, universities, research institutes, and even individuals can apply for medical device registration (FDA registration). At present, China's relevant laws and regulations do not allow universities and other research institutions and clinical units to apply for registration, which is extremely unfavorable for the mobilization of medical device innovation resources and power.

Fan Yubo said, “The Regulations on the Supervision and Management of Medical Devices newly issued by the State Council have made great progress in comparison with the past, optimizing the regulatory policy environment for the development of medical devices. However, if the types of medical devices exceed 10,000, policies and regulations must be more detailed. To be targeted, medical devices with different principles and risks should be measured in the end, and high-risk devices that enter the human body should be more strictly supervised, while some types of diagnostic devices and some principles are clear. Depending on the type of equipment with reliable materials, it may be appropriate to optimize the supervision methods and reduce the registration period and costs."