Medical network - March 8 March 4, 2017, sponsored by the pharmaceutical industry association of 25 medicine CPPCC symposium was held in Beijing. Besides business NPC representatives and CPPCC members, from the state department, health department, the national development and reform commission, planning commission, the ministries and commissions such as food and drug administration, and health experts, such as hospital dean to attend the meeting.
Deputy to the National People's Congress, shandong xinhua medical instrument co., LTD., chairman of Zhao Yixin on behalf of the China association for medical devices industry participant. It is reported, this is the first symposium of the NPC and CPPCC sessions for medical device industry association. Different, this year, medical equipment enterprises on the two sessions in the pharmaceutical industry finally big circle, and issued their own voices.
The blue instrument that parker Zhao Yixin at the meeting on behalf of the Chinese medical device companies a total of three Suggestions are put forward, respectively is "in formulating reasonable fees, reduce the corporate tax rate, to support the development of in vitro diagnostic industry recommended", "about to speed up to develop innovative medical devices into clinical use of the new policy Suggestions, on the domestic high-end medical equipment enterprise out advice sales dilemma".
Some argue that the blue parker instrument has disclosed yesterday, today for micro friends send is provided by the China association for medical devices industry suggestion in full:
A, in formulating reasonable tuition standard, reduce the corporate tax rate, to support the development of in vitro diagnostic industry
Along with the progress of science and technology, the advanced medical equipment application is becoming more common in clinical diagnosis. According to statistics, two-thirds of medical decision making depends on the diagnostic information. Diagnosis technology enterprise in our country after years of unremitting efforts, although has made certain development, and emerged a group of leading enterprises to master the core technology in local areas, have a certain market scale and the foundation, is from the industry in its early years, but due to the long-term clinical diagnosis reagent industry development in our country lags behind the advanced level, compared with a large multinational company, in many aspects, such as capital, technology, talent is a huge gap.
In order to enhance the independent innovation in vitro diagnostic reagent, reinforced with enterprise as the main body, take the market as the guidance, the combination of technical innovation system, greatly improving the capacity of in vitro diagnostic reagent industry in China's domestic and international competition ability, during the period of "11th five-year plan", national "863" program support "biomedical key reagent" for the first time, key projects have achieved good achievements.
Since then, the state council, the national development and reform commission, ministry of science and technology also spoke of in vitro diagnostic in eight files, including the national "twelfth five-year" science and technology development planning ", the "twelfth five-year" biotechnology development planning ", "medical devices" twelfth five-year "plan of science and technology" and so on, the national industrial policy support for the development of in vitro diagnostic industry to create a good external environment.
Has more than 400 in vitro diagnostic companies in our country, the annual sales income over one hundred million yuan only about 20 of enterprise, the industry a good good company also just occupy a relatively small market share, industry concentration degree is low. As the development level and technology level of ascension, in some areas of high-end completion of import substitution, domestic products market share will gradually improve. A batch of high quality domestic leading enterprises to stand out, relying on the progress of product and industry mergers and acquisitions to expand the market share, industry concentration will gradually increase. With foreign counterparts "instrument and reagent" integration development pattern, domestic manufacturer is mainly engaged in production and diagnostic reagents as original overseas agents, products in the domestic current part excellent r&d and production of domestic companies have begun to instrument, model for future products will be made by pure reagent to the integration of instruments and reagents. But at present is still in the development of in vitro diagnostic industry encountered bottleneck. Specific issues are as follows:
A, medical equipment product registration fee standards
In 2015, the state and local testing department started according to the pharmaceutical, medical equipment product registration fee standards ", "charge detailed rules for the implementation of medical equipment product registration (try out)" and the product registration charge fees. More than a year after the implementation, bring a lot of stress. At present, the industry has nearly 20000 registration certificate, annual product registration fee includes the new registration and continue to register the product such as additional cost hundreds of millions of yuan, about 10% of the profits, significantly increased the burden, is not conducive to enterprise innovation and development, also does not conform to the national enterprise burden policy.
1, in vitro diagnostic products variety, and the varieties of a single small sales. Enterprises have hundreds of registration certificate of products in production, a single product with annual sales of tens of millions of dollars even if the industry large varieties of products.
2, medical institutions, inspection costs decline, the enterprise growth in the market. From the registration fee to market prices fell by double extrusion, make the enterprise into troubles.
Suggestion: the national development and reform commission, the state food and drug administration and other relevant departments according to the project fee problem research, formulate reasonable charging standards.
Second, the enterprise value added tax, the burden of enterprise management
Medical device industry scale is small, in the face of opportunities and challenges, more need to encourage and support from the government. And, from the social benefits, medical equipment industry development makes the overall cost reduce disease and curative effect is better.
1, the current relatively high gross profit margin for medical devices industry, VAT tax is heavy. But r&d inputs is high, it is a technology development, update faster industries, and instruments, reagents and other related fields, and the enterprise to the survival and development, is continuing high investment for r&d and introduction of new technology or new products.
2, the real economy management face difficulties. Industry rising cost of raw materials, product prices are lower, such as loan financing difficulties, enterprises encountered new difficulties. Combined with the international tax cuts, the United States market expectations and global impact. These changes to reduce the industry enterprise competitiveness, some companies will therefore difficult to survive.
Suggestion: the fiscal and taxation authorities to reduce the VAT tax, reduce the burden of enterprise management, make medical instrument industry can get healthy development.
Of two, to accelerate to develop innovative medical devices into clinical use of the new policy Suggestions
In the "public entrepreneurship, peoples innovation", under the national major policy of the innovation of the medical device industry policy also appear constantly, but the related policy at present only in upstream. Administration of state food and drug supervision and administration, for example, made innovation to speed up the review of the medical devices for examination and approval policy, innovation product, no effective measures, in the face of the current practice of the relevant provisions of the bidding, procurement policy, because it is the new product, more difficult to be bidding and purchasing.
This kind of situation to actively carry out technological innovation and entrepreneurship emerging medical equipment companies will be fatal.
Exhausted these innovative start-ups in venture capital financing, finally can start selling its products, often cannot help markets mature circulation channels quickly realize the value of the technology innovation, need to quickly build a staff scale, market development ability and international medical giant considerable internal marketing team to participate in market competition. Such a situation, not only increased dramatically enterprise operating costs, increase the risk of failure, will also sharply increase the sharing costs of medical apparatus and instruments, and "one vote", "two votes" to lower the price of medical apparatus and instruments of expectations.
Lack of the medical device industry enterprises and clinical medical experts and scholars participate in, China's medical equipment in the field of circulation reform will continue to cause the healthy development of the medical device industry unpredictable negative effects.
In view of this, to make innovative medical devices used for clinical purposes as soon as possible, reduce the burden of disease diagnosis and treatment costs, reducing patient diagnosis and treatment and the national health insurance payment pressure to contribute. Advice:
1, who planning in the application of bidding/purchasing, support innovative products for clinical use of related policy as soon as possible;
2, organize related circulation policy should by medical equipment management department, medical equipment industry and clinical medical experts and scholars to participate.
3, about the domestic high-end medical equipment enterprise out advice sales dilemma
One, the background and the present situation
"Made in China 2025" key areas technology roadmap made clear the development direction of domestic medical equipment into the field of high-end, the country's "much starker choices-and graver consequences-in planning will be high-end medical equipment is listed as one of the focal areas, support the development of the domestic medical equipment industry.
In the high-end medical equipment research and development, facing the breakthrough core technology, lack of technical personnel, innovative research and development funds into many difficulties, such as block through the way of technology innovation into the high-end field. In 2016 the national scientific and technological innovation's important speech in the conference once again put forward to strengthen the protection of intellectual property rights. Domestic strengthening intellectual property protection system for the technical innovation and healthy development of China's medical equipment industry is substantial policy support.
A domestic focus on tumor minimally invasive surgical high-end medical equipment research and development and industrialization of national high-tech enterprises, is the national ministry of industry and information technology brand cultivation of pilot units and local brand cultivation demonstration units. The medical equipment products through technological innovation for national approval to enter the market, but product into the market is facing the following difficulties:
1, domestic equipment grouping were forced to tender, due to price discrimination, was asked to cost less than import homogeneous brand at least 30%;
2, the current implementation of medical equipment to hang your selection process, "one vote", "two votes" circulation of medical devices in the field of control, lead to technical innovation of domestic medical device companies cannot use the original market mature circulation channels quickly realize the value of the technology innovation;
3, because the Chinese government has yet to improve the intellectual property related to national trade protection measures, in Germany, the United States, such as exhibitions, Europe and the United States medical majors by a local court forced confiscation of Chinese enterprises to participate in the exhibits, for Chinese enterprises "going out strategy" significantly suppressed.
Second, the proposal
1, clearly put forward many times under the state council shall, in accordance with the domestic and foreign alike, the principle of fair treatment, suggested that the domestic each big hospital medical equipment purchasing entry to establish similar same price standard, further create a fair competition environment, realize mutual benefit and win-win results.
2, simplify the medical equipment to hang your screening process, pass laws to get the corresponding registration certificate of the product (including innovations) to implement instant access;
3, perfect the system of bidding evaluation, the real market, ensure that domestic and foreign products enjoys a fair business environment, improving the efficiency of the hospital, meet the demand of different patients go to a doctor.
4, in view of the medical equipment industry, building cross-organizational collaboration platform construction and protection of intellectual property rights, regularly carry out according to the international/domestic patent, intellectual property protection, defence, litigation, the latest regulations, cases, such as training, and keep the business communication with domestic medical equipment enterprises.
Development of health and health, is the basic content of China construction of the CPC central committee and the state council promote health, is to improve the supply structure, the important measures to better adapt to the needs urgently. Domestic medical device companies in the plight of the strength in the field of high-end medical equipment, will hinder the pace of the domestic medical equipment industry to a higher.
Break the dilemma will be conducive to domestic high-end medical equipment and imported homogenous medical instrument to compete, also conducive to keep the innovation of the domestic high-end medical equipment enterprise vitality, promote the domestic independent research and development of high-tech medical equipment enterprise healthy growth. |
