At the annual two sessions of the National Committee of the Chinese People's Political Consultative Conference (CPPCC), Chang Zhaohua, a member of the Standing Committee of the CPPCC National Committee, Vice Chairman of the All-China Federation of Industry and Commerce, and Chairman and CEO of Shanghai Wicresoft Medical Devices (Group) Co., Ltd, said that the pilot "4+7" procurement with volume is one of the exploratory measures of the Health Insurance Bureau to solve the problem of "health insurance gap" in China, which may have a positive effect on reducing drug prices, eliminating some unreasonable intermediate links, and saving limited national health insurance funds; however, this approach has still caused a huge impact in the pharmaceutical industry.
 

However, before the actual effect of the "4+7", especially the possible negative impact on the "double innovation" activities, business environment and national strategy for high-quality development, has been accurately and comprehensively assessed, it is not advisable to rashly extend to the field of high-end medical devices, especially high-value consumables that directly affect patients' life and health.

The reasons are: 1) China's medical high-value consumables industry is still in its infancy, with weak industrial strength, and the gap between its strength and overseas is much larger than that between the pharmaceutical industry and overseas; the "Made in China 2025" and the "13th Five-Year Plan" national strategic emerging industries development plan both emphasize improving the innovation capability and industrialization level of medical devices; 2) the "4+7" pharmaceutical industry is still in its infancy.

(2) The "4+7" pharmaceuticals are mainly based on the "quality and efficacy consistency evaluation", and products that have passed the "consistency evaluation" are, in principle, of the same quality and can be substituted for each other; there is no unified coding system and subdivision standards for high-value medical consumables; most importantly, there is no scientific method to distinguish the different quality levels or grades of high-value consumables, and the usual practice of winning bids at low prices will inevitably lead to the phenomenon of "bad money expelling good money".

(3) High-value consumables are usually updated frequently, and whenever a new generation of products is launched, doctors need to learn and train for a long time and accumulate experience before they can be proficient and carry out the surgery smoothly; if the products that doctors are already proficient in using are hastily replaced, it will definitely affect the quality of surgery and even lead to frequent medical accidents and endanger patients' lives.

(4) The production equipment and production process of high-value consumables are too complex and long for laymen to imagine, and their capacity preparation and improvement is a systematic and continuous process; if small-scale enterprises win the bid at a low price, it is difficult to rapidly increase the capacity in a short period of time and then fail to guarantee the normal supply of products; this may lead to serious consequences that enterprises will only reduce costs and gradually weaken the investment in innovation and lose the motivation and ability to continuously update and iterate, and even have to simplify the production process or use substandard products in order to maintain reasonable profits.

(5) The procurement with volume will certainly kill the emerging personalized medicine in the cradle.

He pointed out that Premier Li Keqiang also pointed out at the meeting of the Federation of Industry and Commerce of the Chinese People's Political Consultative Conference (CPPCC) and the Democratic Alliance for the Betterment and Progress of Hong Kong (DAB) that the bidding process must be premised on fairness and transparency and not affecting the vitality of enterprises' independent innovation. Some innovative high-end medical device companies have just had the first signs of competing with international companies in the market, and if they are thus taken out of the market and lose their research fuel, it will certainly be a devastating blow to domestic innovation.

At the same time, he suggested that.

1, the serious shortage of national health insurance resources is rooted in the serious shortage of national health expenditure and unreasonable investment structure and the lack of social resources in commercial insurance, the primary and main means to solve the "difficult and expensive to see a doctor" should be to enhance government investment in health insurance.

2. The medical high-value consumables industry should be given a certain amount of time to develop, and when the domestic manufacturers have developed and grown to the point where they can compete with multinational companies, and when sufficient data have been accumulated on the basis of drug procurement with volume, the feasibility of high-value consumables procurement with volume should be evaluated after summing up the experience from social and economic benefits, especially health economics.

3. Establish a unified and standardized coding system and quality standard evaluation system for high-value consumables; given the complexity of high-risk implantable consumables, the safety and efficacy of the products can only be evaluated by accumulating sufficient evidence-based medical evidence through a series of clinical trials with long and large capital investment, while the efficacy and prognosis of similar products with no or little evidence-based medical evidence are completely different for patients, so the quality standard for high-value Therefore, the consideration of evidence-based medical evidence must be reflected in the quality standards for high-value consumables. Therefore, it is hoped that the NMPA will provide support for post-marketing clinics, while paying attention to post-marketing regulation.

4. Based on the feasibility study, we should listen to the opinions of the industry, form a pilot program first, and explore in a small scope (variety and geographical area): first, we should discuss scientifically the selection of varieties and specifications for the quantity procurement; second, we should introduce the protection of "innovative products" in the rules for determining the selected varieties, so as to distinguish between "innovative"-oriented products and "innovative"-oriented products. The second is to introduce the protection of "innovative products" in the rules for determining the selected varieties, distinguish between products that are mainly "innovative" and those that are mainly "imitation", protect the enthusiasm of innovation in the industry, and do not take only "low price"; the third is to formulate perfect supporting policies for medical insurance payment, refund, and supply guarantee for high-value consumables. Thirdly, we should formulate a comprehensive policy on medical insurance payment, rebate and supply guarantee, etc.; after the performance of the pilot areas and the expected degree of conformity have been positively recognized by all parties concerned, we will promote the implementation of high-value consumables procurement with volume in a prudent manner.

In addition, Chang Zhaohua also submitted a number of proposals.

It is recommended that patient implant cards be incorporated into pharmacovigilance regulations to more effectively protect patient rights and health safety.

After a patient undergoes an implantation procedure, the manufacturer information, specifications, safety precautions, post-operative follow-up and medication requirements of the implanted device are often the information that patients are most concerned about. Therefore, it is suggested that the State Drug Administration (NMPA) should issue a corresponding specification or guideline document to guide domestic manufacturers of implantable medical devices, promote the implementation of the Unique Medical Device Identification (UDI) requirements, promote the popularization and application of patient implant cards, and play a role in the process of "establishing a supervision and management system that combines government regulation, industry self-regulation and social supervision "play a role in the process of establishing a supervision and management system that combines government regulation, industry self-regulation and social supervision.

It is recommended to closely match the national strategy in the field of high-performance medical devices by laying out discipline-based and enterprise-based state key laboratories.

Match and adapt to the national strategy and international development trend, lay out 3-5 discipline-based State Key Laboratories in the field of high-performance medical devices as soon as possible; lay out and build a number of (5-10) enterprise-based State Key Laboratories; strengthen the training of outstanding talents in science and technology for enterprises, etc.

It is recommended that comprehensive measures be taken to enhance the real profitability of private enterprises to enhance the real sense of access to enterprises.

At this stage, China's private enterprises contribute more than 50% of the country's tax revenue, more than 60% of GDP, more than 70% of technological innovation, more than 80% of urban labor employment and more than 90% of the number of enterprises, but profits account for only 25% and show a declining trend year by year.

For private enterprises, reducing the burden is only a means to an end, while improving profitability is the ultimate goal; the latter requires far more factors to be considered than the former, and its complexity is also higher than the former. It is recommended that the policy orientation of tax and fee reduction for private enterprises be further upgraded to improve and enhance the comprehensive profitability of private enterprises, and that the simple means of reducing tax and fee rates be adjusted to enhance the profit share of private enterprises among all economic agents; that the feasibility of various measures to open source and reduce the burden of private enterprises be further evaluated; and that the profit share of private enterprises be raised from the current 25% to 25% of its GDP and tax revenue within 3-5 years. In 3-5 years, the profit share of private enterprises should be raised from the current 25% to a level corresponding to their GDP and tax revenue share, i.e., between 50% and 60%.

It is recommended to establish a long-term mechanism to actively guide enterprises to strengthen global intellectual property layout to make up for the shortest board of China's high-tech enterprises to participate in global competition.

In the process of internationalization, Chinese enterprises are either trapped in the shackles of intellectual property rights and cannot go out, or they are "naked" in the international market and frequently subjected to litigation, which is due to the unscientific, imperfect or even lack of international layout of intellectual property rights. It is recommended to systematically cultivate Chinese enterprises' awareness of international IPR layout by formulating relevant policies; improve international funding, incentive or subsidy policies and operation methods to encourage domestic enterprises to layout overseas IPR through investment/merger and acquisition of IPR autonomy; optimize domestic IPR judicial construction and take the lead in aligning with Europe and the United States as soon as possible in regions with conditions, so as to increase the cost of IPR infringement, especially the amount of punitive damages. The cost of IPR infringement, especially the amount of punitive damages, should be substantially increased to the same level as that in Europe and the United States, so as to warn and strengthen domestic enterprises' awareness of "life and death" IPR and enhance their combat ability in the IPR offensive and defensive battles in the domestic market.

It is proposed to set up a "China Health Research Institute" in Zhangjiang National Science Center to accelerate the cultivation of compound and cutting-edge medical research talents in China.

China's research funding is mainly focused on major critical areas that the country needs to overcome urgently, and not enough support is given to encourage scientists to explore freely, making it difficult to carry out "high failure rate but breakthrough" research. In addition, cutting-edge biomedical research requires a high level of comprehensive quality of scientists, and it often takes another 5-10 years of training after obtaining a doctorate in medicine or engineering to become a scientist with certain independent research ability, and China obviously lacks such a systematic institution and mechanism for nurturing high quality talents of complex type.

It is recommended that a "China Institutes of Health (CIH)" should be set up as soon as possible under the direct leadership of a ministry of the State Council to design the overall strategy and implementation roadmap of biomedical research in China, taking into account the practices and experiences of other countries in the world. The CIH will integrate the relevant research forces and resources in China from the top level, coordinate the work of multiple research institutions and scientists in different fields, and urgently solve the problems of the large number of various medical research institutions, scattered forces, uneven quality of practitioners and lack of unified leadership at the national level in China.

The CIH will coordinate applications for funds related to biomedical research and enhance coordination among research programs at universities, research institutions, hospitals and enterprises; develop and implement medium- and long-term strategies for human resources training in the biomedical field through the CIH platform. Establishing a system of academicians of medical schools in addition to the academicians of the Academy of Sciences and the Academy of Engineering; establishing the headquarters of the CIH "The headquarter of CIH is located in Zhangjiang National Science Center, where the concentration of biomedical talents is obvious and the concentration of large research devices and facilities is relatively high, and the foundation of scientific research and industrialization has been established, and the exchange of personnel, technology and information with overseas is close.