China will become the second largest pharmaceutical market urgent need for drug innovation policy support
Release time: 2012-03-14 & nbsp & nbsp & nbsp Source:
Representative of the National People's Congress、Xiao Wei, Chairman of Kangyuan Pharmaceutical, proposed，Be sure to improve the independent innovation strength of the Chinese national pharmaceutical industry，Guarantee national strategic security。Xiao Wei thinks，In 2011, the total output value of my country's pharmaceutical industry reached 1522.3 billion yuan，The total market volume has become the third largest pharmaceutical market in the world。With the orderly progress of the new medical reform and the gradual formation of an older society，In the next ten years，my country's pharmaceutical market will maintain rapid growth，It is expected that the total output value of my country's pharmaceutical industry will exceed 4 trillion yuan in 2019，Become the second largest pharmaceutical market in the world。
But at present, my country is still just a major pharmaceutical country，The ability of the national pharmaceutical industry is low，There is still a big gap between the power of the pharmaceutical power。In the field of market medication in the high -end hospital in my country，joint venture foreign drugs, which are mainly innovative drugs, have occupied 48%of the share，The share of domestic medicines is constantly eaten; and the sales proportion of domestic one -type new drugs is less than 5%，Far as much as the proportion of joint venture foreign -invested innovative drugs。At the same time，In recent years, major international multinational pharmaceutical giants have established a drug research and development center in my country，Further robbing my country's drug research and development resources，Many unfavorable factor brings a lot of unfavorable factors to the competitive environment developed by weak Chinese drugs。If my country's national pharmaceutical industry innovation ability will not be improved，The competitiveness of the national pharmaceutical industry market will be at a significant disadvantage，The domestic pharmaceutical market will give up the hands。Long this time，National People's Medical Supply will be subject to people，directly affects my country's drug strategic safety。So，Improvement of the self -innovation of the national pharmaceutical industry is imminent。
1. The main problems of the existence of drug innovation in my country
We know，Sustainable development of independent innovation for my country's national pharmaceutical industry，It is very important to ensure the strategic safety of our country。But at the same time, you should also be soberly realized，Independent innovation of drugs in my country also has many constraints and deep problems。It is mainly reflected in:
(1) The government has limited support for innovative pharmaceutical companies，It is not conducive to forming an independent innovation environment that encourages pharmaceutical companies to develop drugs for drug development
1. The government has limited support for pharmaceutical innovative enterprises。International experience show，Government's incentive policy is important to guide the healthy development of the pharmaceutical industry。The U.S. government In order to encourage innovative drug development，Established related reduction tax、Federal funding subsidy、Accelerating measures and other measures for new drug reviews。The Indian government also provides corporate technological innovation including tax reduction and exemption、Customs Tariff Exemption、Financial support and subsidy、Government rewards and other preferential policies。From the perspective of the number of innovative enterprises，R & D -based pharmaceutical industry enterprises lower proportion，The proportion of enterprises with scientific research institutions is only 21%。Although the Chinese government has issued relevant policies in encouraging the new drug innovation mechanism of pharmaceutical industry enterprises，But the implementation is not good。
2. The government's self -innovated capital utilization rate for pharmaceutical companies is not high。Although the major new drug creation investment in my country during the 11th Five -Year Plan period is about 20 billion yuan，From the perspective of R & D results，There are 13 categories now，25 varieties，A total of more than 300 specifications of new biological drugs are approved，Among them, there are 9 varieties in the original innovative medicine，It can be seen that the utilization rate of funds is not high。On the one hand, because of the new drug standards, there is a certain vagueness，Excessive new drug projects Stake Sports Bettingstake online sports bettingcaused by the declaration，Caused the use of funds too much。According to statistics，During the "Eleventh Five -Year Plan" period, the actual government support funds of the average single new drug project during the period of "Eleventh Five -Year Plan" period are only about 40 million yuan，It is far from satisfying the actual R & D investment of the average of about 8 years in pharmaceutical companies; on the other hand,，Excessive application for new drug projects can easily cause a waste of funds to a certain extent。
3. Insufficient integration of internal and external resources，Inadequate linkage mechanism of industry, university and research。At present, the transition and transition of the self -innovation of the enterprise with the research institutions as the main body，Although my country owns 4579 pharmaceutical enterprises，746 of various scientific research institutions，However, due to the insufficient integration of internal and external resources，Over -decentralized industry -university -research，Especially the government promoted "political, industry, college and research" mode，It is impossible to form an effective linkage mechanism，Disclosure from the development of new drugs and market demand。In recent years, major international multinational pharmaceutical giants have established nearly 20 pharmaceutical research and development centers in my country，Further robbing my country's drug research and development resources，Forming strong competitive pressure on my country's new drug innovation。
(2) Low the capacity of innovative drug research and development，Is not conducive
1. The approval policy of the new drug is not perfect，Especially reflected in the approval time of new drugs。Comparison with the international market，U.S. drug approval takes direct declaration、The declaration mechanism of the first -level review，Pay attention to the bilateral communication between the review agency and the enterprise during the drug approval process，and targeted simplified review procedures，and my country's new drug environment is inadequate，If the information is not good、Excessive approval cycle, etc.，Caused a large negative effect on the research and development of innovative drugs。Take the approval process of the application application of new drugs as an example，The US Food and Drug Administration (FDA) must make a decision within 30 days，If this period is over, you will not make a decision，Pharmaceutical companies can start clinical trials。But in the country，After clinical application is submitted，It takes 150-200 days to know if it can be launched in clinical trials。Both comparison，Only clinical declaration of this link，Domestic approval time is 5 times compared to foreign countries。
2. Corporate capital investment intensity and low personnel input intensity。Comparison 2000 China、Investment intensity and personnel investment intensity of pharmaceutical companies in the United States and Europe and the United States，You can see clearly，There is still a large gap in Chinese pharmaceutical companies。One aspect，my country's proportion of China ’s investment in drug research and development is relatively low。In recent years，The proportion of R & D investment in the industry is about 2%-3%average，Even the best R & D enterprise in China，Its R & D investment only accounts for about 8%of sales revenue，and the average R & D investment of multinational pharmaceutical companies reaches more than 15%，up to 27%。On the other hand，my country's investment personnel investment intensity is less than 10%，and the investment intensity of R & D personnel in European and American countries is basically maintained at 18%。
3. The return on output in my country's innovative drug market is obviously low。Current，The importance of "heavy bombs" innovative drugs to pharmaceutical companies is obvious。One aspect，From the perspective of the number of innovative drugs，The number of new drugs with substantial significance in my country is obviously small。Since 1986，Nearly 40 self -developed types of chemicals approved by my country，On average, only 1-2 per year，far lower than the approval speed of 5-8 new molecular entities per year in the United States。On the other hand，The top ten globally in the world in 2010，"Bomb Bomb" type innovative drug sales reached 8.7%，Compound growth rate in the past ten years reached 6.47%，higher than the average increase in global drug sales。From 1997 to 2010，The average sales of 5 years after the listing of American original drugs reached 880 million US dollars，profit margins reached 30%or more，and my country's innovative drugs have been listed for 5 years to sell over 100 million yuan, there are very few varieties，Even the first three years before the listing is still at a loss。
(3) Performable transformation capacity of innovative drug markets，Not conducive to the sustainable investment of the independent innovation of the national pharmaceutical industry drug
1. Price policy is not conducive to the market application of innovative drugs。Looking at the international market，Since 2002，The Japanese government's increase in the price increase from 40%to 70%-120%in 2008。At the same time，The average R & D investment of the top ten pharmaceutical companies in Japan，also increased from 13.8%of sales to 20.9%。Give a certain price support to innovative drugs，It can correctly guide the virtuous cycle of the entire industrial chain。stake sports betting appAt stake sports betting apppresent，Even colleagues with imitation drugs，Seriously combating the enthusiasm of innovative pharmaceutical companies。
2. The relevant regulations lacking clinical admission of innovative drugs in the basic drug system。After the implementation of my country's basic drug system，Innovative drugs are difficult to enter the basic drug directory due to price reasons，Make the sales of the innovative drug market limited。Therefore, you should learn from WHO and advanced national basic drug policies，The relationship between the principle of balance of basic drug selection and drug innovation。Should consider independent innovative factors，Given a certain proportion of the national pharmaceutical industry innovation drugs，to fully mobilize the enthusiasm of the innovation of national pharmaceutical companies。
3. The medical insurance directory system has a greater impact on the clinical application of innovative drugs。An important reason why innovative drugs are difficult to market is the lack of support for medical insurance policies。The "National Public Medical Reimbursement Catalog" formulated by the former National Public Medical Office of the Ministry of Health，National Category、Two types of new drugs naturally enter the directory，At the same time, there is a country、A new category of new drugs automatically entered the "National Basic Medicine Catalog" encouragement policy，But when it was later revised as "Medical Insurance Catalog"，These encouraging policies have not continued，As a result, it is difficult for innovative drugs to enter the hospital's main market。At the same time，The update of the medical insurance directory has a certain period of time，Usually 1-2 years。This has caused the sales of innovative drugs within a certain period of time after the listing.。How to enter the medical insurance directory for innovative drugs，Lack of relevant policy documents now。
4. Drug tendering policy is not conducive to innovative enthusiasm for research and development of drugs。At present, the "low -price" bidding system for drug procurement of hospitals，seriously affects the enthusiasm of the company's development of innovative drugs。Pharmaceutical procurement bidding method，Makes high -quality products of brand companies、Innovative drugs，Because of cost、The price is relatively high and cannot enter the hospital for sale，Cause extremely unreasonable phenomenon。At the same time，Bidding and purchase of drugs in various places is not performed every year，Sometimes the first class of the company is three years。The deadline for patented by innovative drugs is 20 years，But in the past 20 years, it has not started from the listing of new medicines，often starts from the application project。If the R & D time itself is long，Spend a few years of Kung Fu waiting for the bidding of the medicine，The patent maintenance time that the company can enjoy is greatly shortened。Enterprise invested huge manpower、New drug products developed and developed by financial resources，Can't successfully enter the hospital's mainstream sales channel，The enthusiasm for the investment of new drug innovation for enterprises is a heavy blow，It will directly affect the sustainable development of the innovative research of new drugs in my country。
2: Main suggestions:
(1) Further increase the support of drug independent innovation enterprises，Forms a good innovative environment that encourages pharmaceutical companies to develop drugs for drugs
1. Encouragement、Support the transformation of the national pharmaceutical industry from the research and development of innovative drug research and development。
The problem of the dislocation of innovation subjects in my country's pharmaceutical industry。So，The government wants to learn from the "Silicon Valley Model" in the United States，The British "Partner Plan"，Japan's "Official Property Academic Research" cooperation mode，Increase support for domestic innovative enterprises，Relevant departments through integrated resources，Guide and support innovation elements (Scientific Institute、Scientific research funds、Scientific Research Talents, etc.) Gathering to medical companies with innovative ability。One aspect，It can promote the improvement of the concentration of my country's pharmaceutical industry，Form a scale economy，Perform the cost of drug production，Give the people for a real profit。On the other hand，It also accelerates the transformation process of my country's pharmaceutical industry。
2. Increase the fiscal policy of innovative enterprises、Support of Patent Protection Policy。
In terms of financial policy support，The government should focus on increasing the pre -tax deduction policy for the research and development costs of pharmaceutical companies、Government Science and Technology Fund Funding Support for the R & D of Drugs R & D、Government procurement policy of independent innovation technology and products、Inspired the improvement of policies such as financial support for enterprises for innovation。
In terms of patent protection policy，You can learn from developed countries such as the United States，Patent Term Extension and market exclusive protection (Patent Term Extension) after the approval is given (Market Exclusion)。The purpose of 2 protection stake online sports bettingstake online sports bettingis the time that the drugs lost due to R & D and approval，Make the new drug product from competing within a limited time，Encourage the development of innovative drugs。
(2) Further improve the drug registration approval policy，Constructing an innovative drug "green channel" mechanism
1. Strict "new medicine" standard，Encourage innovation in essence。
Suggestions Strict new drug definition，Improve the standard of medicine。Clarify the definition of new drugs in the new "Administrative Measures for the Registration of Drugs"，Gradually connect with the international NCE standard。Drug Quality Standards、The improvement of the registration standard is ensuring the safety of drugs、On the premise of effectiveness，Internationalization of my country's innovative drug research and development level，To realize my country's pharmaceutical industry as soon as possible。The approval time (IND) should be appropriately accelerated to appropriately accelerate the approval time (IND)，Strive to be in line with international。
2. Improve the procedures for the approval of innovative drug listing.
In 2007, the "Administrative Measures for the Registration of Drugs", although it clarifies the transition from rapid approval in my country's pharmaceutical registration supervision system to special approval，But the special approval policy of the drug at this stage has not yet been implemented，and the relevant implementation rules have not been introduced。It is recommended to be based on the special approval policy of the drug at this stage，Refine the principles of selection of special approval drugs as soon as possible、Short the time limit for approval of special approval qualifications，To better achieve the original intention of incentive innovation。3. Accelerate the progress of drug technology review。
The number of medicines reporting in recent years has been reduced，The proportion of new drugs also increases，But the approval time limit exceeds the time limit specified in the "Administrative Measures for the Registration of Drugs"，seriously affects the enthusiasm of the enterprise，At the same time, the long -term idle of production equipment，increased research costs。It is recommended to appreciate the appraisal expert、Reduce unnecessary procedures，Make sure to complete the review work within the prescribed time limit。4. For the approval of a class of innovative drugs, it is recommended to implement the principle of leniency and strictness。
Due to the long research and development cycle of the first type of drug，Due to the long research and development cycle of the first type of drug，Under the premise of ensuring safety，Allowing production processes in preclinical research、There are certain changes in the process of approval production。
(3) Increase the policy orientation of the transformation of innovative drug markets，Promoting the self -innovation and sustainability development of national pharmaceutical industrial drugs
1. Clear innovative evaluation standard，Improve the drug pricing mechanism。
First, the pricing mechanism should encourage independent innovation，The price of products with independent intellectual property rights should take into account the research and development cost of the enterprise。Current，In the pricing of drugs in my country, the drug uses registered classification method for category，Not only complicated items，and cannot fully reflect the technical value -added factor of innovative drugs。For the separate pricing patented drugs and the original drug, the original drug has not yet formed a complete pricing classification standard。So，my country should establish a standard for innovative drug pricing as soon as possible，Gives different degrees of stimulation and protection of patents of different degrees of innovation，Ensure that innovative drugs can recover its R & D costs through the market and obtain reasonable profits。It is recommended to introduce the drug pricing mechanism and specific measures that are tilted to independent innovation drugs。
2. Encourage innovative drugs to include the basic drug directory and medical insurance directory。
Basic drugs should be developed for the disease spectrum of Chinese people。The selection of drugs is first to cover the disease spectrum of the Chinese population，Followed by ensuring the quality, the better the price is better。It is recommended to follow the spirit of "government first-term science and technology development planning outline (2006-2020)" and its supporting policies in accordance with the spirit of "government first purchase" for encouraging innovative products，In principle, the design of the national basic drug directory can reflect the support of independent innovation。At the same time，Combined with the characteristics of Chinese medication，Organizes by the Ministry of Health and Social Security Organization experts organize the existing independent innovative drugs in my country，In Pharmacology、Effect、Evaluation of safety and drug economy，The effect will be precise、Drug safety、Reasonable price of Chinese independent innovation drugs is included in the national basic drug catalog。
Innovative drugs should enter the medical insurance directory as soon as possible，can the general public enjoy the benefits brought about by the progress of medical science。More importantly，After entering the medical insurance catalog，Can directly enter the bidding My stake betting appstake online sports bettingcatalog of the provinces to participate in bidding。It is recommended to introduce relevant policy documents for the specific measures to enter the two directory to independent innovation drugs。At the same time，Considering the actual positioning of medical insurance drugs and basic drugs in cheap drugs，It is recommended that the government must introduce the relevant policies for the relevant policies of the medical insurance directory and the basic drug directory at the same time.。
3. Improve the hospital bidding system of hospitals.
my country has implemented drug bidding for more than 10 years，The original design of this system is through market competition，Purchase of high -priced and cheap medicines。In recent years，For the problems that occur in it，Government departments have continuously carried out exploration and adjustments。The state should encourage innovative drugs to enter the clinical use of medicine as soon as possible，instead of simply bidding for bidding。For independent innovative drugs，It should be introduced to related differential policies，On the one hand, the price of innovative drugs is given to certain protection，Make sure the company's R & D cost recovery。On the other hand，Ensure that the advancement of pharmaceutical technology will benefit the people。
4. Establish a new mechanism for clinical application of the national pharmaceutical industry's independent innovation drugs。
For independent innovative drugs，Whether it is a drug pricing mechanism，Drug reimbursement mechanism，Still the bidding mechanism of medicine，It is recommended to start from the perspective of national drug strategic safety，Through market competitive orientation，Establish a new mechanism for clinical applications of independent innovation drugs in the national pharmaceutical industry，In pricing power、Reimbursement scope and proportion, and drug tender preferred to choose the independent innovation of the national pharmaceutical industry，Establishing a clinician encouraging policy of the national pharmaceutical industry independent innovation drugs under the same conditions，Expand the clinical use of the self -innovative drugs of the national pharmaceutical industry，The enthusiasm for promoting the independent innovation of national pharmaceutical industry drugs，Create a good independent innovation environment for my country's national pharmaceutical industry，Strategic guaranteeing my country ’s drug safety。
It can be seen from the history of global pharmaceutical development，The pharmaceutical industry has always been a high investment、High risk、High -produced fields。If there is not enough capital investment and policy encouragement，It will not promote the improvement of medical innovation capabilities。Independent innovation is the only way for my country to move from a major pharmaceutical country to a pharmaceutical country。Improving the ability to innovate in China ’s national pharmaceutical industry，is the basic guarantee for the health of the people in our country。
As a representative of the two sessions who understand the actual situation of the pharmaceutical industry，We hope that the government is standing at the strategic height of national drug safety，Pay attention to the status quo of the lack of innovation in the national pharmaceutical industry，Take strong measures as soon as possible，Increase the government's support for innovative pharmaceutical companies; further improve the drug registration approval policy，Build the "green channel" mechanism of innovative drugs; increase policy orientation of the transformation of the national pharmaceutical industry innovation drug market，Promote the health of my country's national pharmaceutical industry、Order、Quick Development。
But at present, my country is still just a major pharmaceutical country，The ability of the national pharmaceutical industry is low，There is still a big gap between the power of the pharmaceutical power。In the field of market medication in the high -end hospital in my country，joint venture foreign drugs, which are mainly innovative drugs, have occupied 48%of the share，The share of domestic medicines is constantly eaten; and the sales proportion of domestic one -type new drugs is less than 5%，Far as much as the proportion of joint venture foreign -invested innovative drugs。At the same time，In recent years, major international multinational pharmaceutical giants have established a drug research and development center in my country，Further robbing my country's drug research and development resources，Many unfavorable factor brings a lot of unfavorable factors to the competitive environment developed by weak Chinese drugs。If my country's national pharmaceutical industry innovation ability will not be improved，The competitiveness of the national pharmaceutical industry market will be at a significant disadvantage，The domestic pharmaceutical market will give up the hands。Long this time，National People's Medical Supply will be subject to people，directly affects my country's drug strategic safety。So，Improvement of the self -innovation of the national pharmaceutical industry is imminent。
1. The main problems of the existence of drug innovation in my country
We know，Sustainable development of independent innovation for my country's national pharmaceutical industry，It is very important to ensure the strategic safety of our country。But at the same time, you should also be soberly realized，Independent innovation of drugs in my country also has many constraints and deep problems。It is mainly reflected in:
(1) The government has limited support for innovative pharmaceutical companies，It is not conducive to forming an independent innovation environment that encourages pharmaceutical companies to develop drugs for drug development
1. The government has limited support for pharmaceutical innovative enterprises。International experience show，Government's incentive policy is important to guide the healthy development of the pharmaceutical industry。The U.S. government In order to encourage innovative drug development，Established related reduction tax、Federal funding subsidy、Accelerating measures and other measures for new drug reviews。The Indian government also provides corporate technological innovation including tax reduction and exemption、Customs Tariff Exemption、Financial support and subsidy、Government rewards and other preferential policies。From the perspective of the number of innovative enterprises，R & D -based pharmaceutical industry enterprises lower proportion，The proportion of enterprises with scientific research institutions is only 21%。Although the Chinese government has issued relevant policies in encouraging the new drug innovation mechanism of pharmaceutical industry enterprises，But the implementation is not good。
2. The government's self -innovated capital utilization rate for pharmaceutical companies is not high。Although the major new drug creation investment in my country during the 11th Five -Year Plan period is about 20 billion yuan，From the perspective of R & D results，There are 13 categories now，25 varieties，A total of more than 300 specifications of new biological drugs are approved，Among them, there are 9 varieties in the original innovative medicine，It can be seen that the utilization rate of funds is not high。On the one hand, because of the new drug standards, there is a certain vagueness，Excessive new drug projects Stake Sports Bettingstake online sports bettingcaused by the declaration，Caused the use of funds too much。According to statistics，During the "Eleventh Five -Year Plan" period, the actual government support funds of the average single new drug project during the period of "Eleventh Five -Year Plan" period are only about 40 million yuan，It is far from satisfying the actual R & D investment of the average of about 8 years in pharmaceutical companies; on the other hand,，Excessive application for new drug projects can easily cause a waste of funds to a certain extent。
3. Insufficient integration of internal and external resources，Inadequate linkage mechanism of industry, university and research。At present, the transition and transition of the self -innovation of the enterprise with the research institutions as the main body，Although my country owns 4579 pharmaceutical enterprises，746 of various scientific research institutions，However, due to the insufficient integration of internal and external resources，Over -decentralized industry -university -research，Especially the government promoted "political, industry, college and research" mode，It is impossible to form an effective linkage mechanism，Disclosure from the development of new drugs and market demand。In recent years, major international multinational pharmaceutical giants have established nearly 20 pharmaceutical research and development centers in my country，Further robbing my country's drug research and development resources，Forming strong competitive pressure on my country's new drug innovation。
(2) Low the capacity of innovative drug research and development，Is not conducive
1. The approval policy of the new drug is not perfect，Especially reflected in the approval time of new drugs。Comparison with the international market，U.S. drug approval takes direct declaration、The declaration mechanism of the first -level review，Pay attention to the bilateral communication between the review agency and the enterprise during the drug approval process，and targeted simplified review procedures，and my country's new drug environment is inadequate，If the information is not good、Excessive approval cycle, etc.，Caused a large negative effect on the research and development of innovative drugs。Take the approval process of the application application of new drugs as an example，The US Food and Drug Administration (FDA) must make a decision within 30 days，If this period is over, you will not make a decision，Pharmaceutical companies can start clinical trials。But in the country，After clinical application is submitted，It takes 150-200 days to know if it can be launched in clinical trials。Both comparison，Only clinical declaration of this link，Domestic approval time is 5 times compared to foreign countries。
2. Corporate capital investment intensity and low personnel input intensity。Comparison 2000 China、Investment intensity and personnel investment intensity of pharmaceutical companies in the United States and Europe and the United States，You can see clearly，There is still a large gap in Chinese pharmaceutical companies。One aspect，my country's proportion of China ’s investment in drug research and development is relatively low。In recent years，The proportion of R & D investment in the industry is about 2%-3%average，Even the best R & D enterprise in China，Its R & D investment only accounts for about 8%of sales revenue，and the average R & D investment of multinational pharmaceutical companies reaches more than 15%，up to 27%。On the other hand，my country's investment personnel investment intensity is less than 10%，and the investment intensity of R & D personnel in European and American countries is basically maintained at 18%。
3. The return on output in my country's innovative drug market is obviously low。Current，The importance of "heavy bombs" innovative drugs to pharmaceutical companies is obvious。One aspect，From the perspective of the number of innovative drugs，The number of new drugs with substantial significance in my country is obviously small。Since 1986，Nearly 40 self -developed types of chemicals approved by my country，On average, only 1-2 per year，far lower than the approval speed of 5-8 new molecular entities per year in the United States。On the other hand，The top ten globally in the world in 2010，"Bomb Bomb" type innovative drug sales reached 8.7%，Compound growth rate in the past ten years reached 6.47%，higher than the average increase in global drug sales。From 1997 to 2010，The average sales of 5 years after the listing of American original drugs reached 880 million US dollars，profit margins reached 30%or more，and my country's innovative drugs have been listed for 5 years to sell over 100 million yuan, there are very few varieties，Even the first three years before the listing is still at a loss。
(3) Performable transformation capacity of innovative drug markets，Not conducive to the sustainable investment of the independent innovation of the national pharmaceutical industry drug
1. Price policy is not conducive to the market application of innovative drugs。Looking at the international market，Since 2002，The Japanese government's increase in the price increase from 40%to 70%-120%in 2008。At the same time，The average R & D investment of the top ten pharmaceutical companies in Japan，also increased from 13.8%of sales to 20.9%。Give a certain price support to innovative drugs，It can correctly guide the virtuous cycle of the entire industrial chain。stake sports betting appAt stake sports betting apppresent，Even colleagues with imitation drugs，Seriously combating the enthusiasm of innovative pharmaceutical companies。
2. The relevant regulations lacking clinical admission of innovative drugs in the basic drug system。After the implementation of my country's basic drug system，Innovative drugs are difficult to enter the basic drug directory due to price reasons，Make the sales of the innovative drug market limited。Therefore, you should learn from WHO and advanced national basic drug policies，The relationship between the principle of balance of basic drug selection and drug innovation。Should consider independent innovative factors，Given a certain proportion of the national pharmaceutical industry innovation drugs，to fully mobilize the enthusiasm of the innovation of national pharmaceutical companies。
3. The medical insurance directory system has a greater impact on the clinical application of innovative drugs。An important reason why innovative drugs are difficult to market is the lack of support for medical insurance policies。The "National Public Medical Reimbursement Catalog" formulated by the former National Public Medical Office of the Ministry of Health，National Category、Two types of new drugs naturally enter the directory，At the same time, there is a country、A new category of new drugs automatically entered the "National Basic Medicine Catalog" encouragement policy，But when it was later revised as "Medical Insurance Catalog"，These encouraging policies have not continued，As a result, it is difficult for innovative drugs to enter the hospital's main market。At the same time，The update of the medical insurance directory has a certain period of time，Usually 1-2 years。This has caused the sales of innovative drugs within a certain period of time after the listing.。How to enter the medical insurance directory for innovative drugs，Lack of relevant policy documents now。
4. Drug tendering policy is not conducive to innovative enthusiasm for research and development of drugs。At present, the "low -price" bidding system for drug procurement of hospitals，seriously affects the enthusiasm of the company's development of innovative drugs。Pharmaceutical procurement bidding method，Makes high -quality products of brand companies、Innovative drugs，Because of cost、The price is relatively high and cannot enter the hospital for sale，Cause extremely unreasonable phenomenon。At the same time，Bidding and purchase of drugs in various places is not performed every year，Sometimes the first class of the company is three years。The deadline for patented by innovative drugs is 20 years，But in the past 20 years, it has not started from the listing of new medicines，often starts from the application project。If the R & D time itself is long，Spend a few years of Kung Fu waiting for the bidding of the medicine，The patent maintenance time that the company can enjoy is greatly shortened。Enterprise invested huge manpower、New drug products developed and developed by financial resources，Can't successfully enter the hospital's mainstream sales channel，The enthusiasm for the investment of new drug innovation for enterprises is a heavy blow，It will directly affect the sustainable development of the innovative research of new drugs in my country。
2: Main suggestions:
(1) Further increase the support of drug independent innovation enterprises，Forms a good innovative environment that encourages pharmaceutical companies to develop drugs for drugs
1. Encouragement、Support the transformation of the national pharmaceutical industry from the research and development of innovative drug research and development。
The problem of the dislocation of innovation subjects in my country's pharmaceutical industry。So，The government wants to learn from the "Silicon Valley Model" in the United States，The British "Partner Plan"，Japan's "Official Property Academic Research" cooperation mode，Increase support for domestic innovative enterprises，Relevant departments through integrated resources，Guide and support innovation elements (Scientific Institute、Scientific research funds、Scientific Research Talents, etc.) Gathering to medical companies with innovative ability。One aspect，It can promote the improvement of the concentration of my country's pharmaceutical industry，Form a scale economy，Perform the cost of drug production，Give the people for a real profit。On the other hand，It also accelerates the transformation process of my country's pharmaceutical industry。
2. Increase the fiscal policy of innovative enterprises、Support of Patent Protection Policy。
In terms of financial policy support，The government should focus on increasing the pre -tax deduction policy for the research and development costs of pharmaceutical companies、Government Science and Technology Fund Funding Support for the R & D of Drugs R & D、Government procurement policy of independent innovation technology and products、Inspired the improvement of policies such as financial support for enterprises for innovation。
In terms of patent protection policy，You can learn from developed countries such as the United States，Patent Term Extension and market exclusive protection (Patent Term Extension) after the approval is given (Market Exclusion)。The purpose of 2 protection stake online sports bettingstake online sports bettingis the time that the drugs lost due to R & D and approval，Make the new drug product from competing within a limited time，Encourage the development of innovative drugs。
(2) Further improve the drug registration approval policy，Constructing an innovative drug "green channel" mechanism
1. Strict "new medicine" standard，Encourage innovation in essence。
Suggestions Strict new drug definition，Improve the standard of medicine。Clarify the definition of new drugs in the new "Administrative Measures for the Registration of Drugs"，Gradually connect with the international NCE standard。Drug Quality Standards、The improvement of the registration standard is ensuring the safety of drugs、On the premise of effectiveness，Internationalization of my country's innovative drug research and development level，To realize my country's pharmaceutical industry as soon as possible。The approval time (IND) should be appropriately accelerated to appropriately accelerate the approval time (IND)，Strive to be in line with international。
2. Improve the procedures for the approval of innovative drug listing.
In 2007, the "Administrative Measures for the Registration of Drugs", although it clarifies the transition from rapid approval in my country's pharmaceutical registration supervision system to special approval，But the special approval policy of the drug at this stage has not yet been implemented，and the relevant implementation rules have not been introduced。It is recommended to be based on the special approval policy of the drug at this stage，Refine the principles of selection of special approval drugs as soon as possible、Short the time limit for approval of special approval qualifications，To better achieve the original intention of incentive innovation。3. Accelerate the progress of drug technology review。
The number of medicines reporting in recent years has been reduced，The proportion of new drugs also increases，But the approval time limit exceeds the time limit specified in the "Administrative Measures for the Registration of Drugs"，seriously affects the enthusiasm of the enterprise，At the same time, the long -term idle of production equipment，increased research costs。It is recommended to appreciate the appraisal expert、Reduce unnecessary procedures，Make sure to complete the review work within the prescribed time limit。4. For the approval of a class of innovative drugs, it is recommended to implement the principle of leniency and strictness。
Due to the long research and development cycle of the first type of drug，Due to the long research and development cycle of the first type of drug，Under the premise of ensuring safety，Allowing production processes in preclinical research、There are certain changes in the process of approval production。
(3) Increase the policy orientation of the transformation of innovative drug markets，Promoting the self -innovation and sustainability development of national pharmaceutical industrial drugs
1. Clear innovative evaluation standard，Improve the drug pricing mechanism。
First, the pricing mechanism should encourage independent innovation，The price of products with independent intellectual property rights should take into account the research and development cost of the enterprise。Current，In the pricing of drugs in my country, the drug uses registered classification method for category，Not only complicated items，and cannot fully reflect the technical value -added factor of innovative drugs。For the separate pricing patented drugs and the original drug, the original drug has not yet formed a complete pricing classification standard。So，my country should establish a standard for innovative drug pricing as soon as possible，Gives different degrees of stimulation and protection of patents of different degrees of innovation，Ensure that innovative drugs can recover its R & D costs through the market and obtain reasonable profits。It is recommended to introduce the drug pricing mechanism and specific measures that are tilted to independent innovation drugs。
2. Encourage innovative drugs to include the basic drug directory and medical insurance directory。
Basic drugs should be developed for the disease spectrum of Chinese people。The selection of drugs is first to cover the disease spectrum of the Chinese population，Followed by ensuring the quality, the better the price is better。It is recommended to follow the spirit of "government first-term science and technology development planning outline (2006-2020)" and its supporting policies in accordance with the spirit of "government first purchase" for encouraging innovative products，In principle, the design of the national basic drug directory can reflect the support of independent innovation。At the same time，Combined with the characteristics of Chinese medication，Organizes by the Ministry of Health and Social Security Organization experts organize the existing independent innovative drugs in my country，In Pharmacology、Effect、Evaluation of safety and drug economy，The effect will be precise、Drug safety、Reasonable price of Chinese independent innovation drugs is included in the national basic drug catalog。
Innovative drugs should enter the medical insurance directory as soon as possible，can the general public enjoy the benefits brought about by the progress of medical science。More importantly，After entering the medical insurance catalog，Can directly enter the bidding My stake betting appstake online sports bettingcatalog of the provinces to participate in bidding。It is recommended to introduce relevant policy documents for the specific measures to enter the two directory to independent innovation drugs。At the same time，Considering the actual positioning of medical insurance drugs and basic drugs in cheap drugs，It is recommended that the government must introduce the relevant policies for the relevant policies of the medical insurance directory and the basic drug directory at the same time.。
3. Improve the hospital bidding system of hospitals.
my country has implemented drug bidding for more than 10 years，The original design of this system is through market competition，Purchase of high -priced and cheap medicines。In recent years，For the problems that occur in it，Government departments have continuously carried out exploration and adjustments。The state should encourage innovative drugs to enter the clinical use of medicine as soon as possible，instead of simply bidding for bidding。For independent innovative drugs，It should be introduced to related differential policies，On the one hand, the price of innovative drugs is given to certain protection，Make sure the company's R & D cost recovery。On the other hand，Ensure that the advancement of pharmaceutical technology will benefit the people。
4. Establish a new mechanism for clinical application of the national pharmaceutical industry's independent innovation drugs。
For independent innovative drugs，Whether it is a drug pricing mechanism，Drug reimbursement mechanism，Still the bidding mechanism of medicine，It is recommended to start from the perspective of national drug strategic safety，Through market competitive orientation，Establish a new mechanism for clinical applications of independent innovation drugs in the national pharmaceutical industry，In pricing power、Reimbursement scope and proportion, and drug tender preferred to choose the independent innovation of the national pharmaceutical industry，Establishing a clinician encouraging policy of the national pharmaceutical industry independent innovation drugs under the same conditions，Expand the clinical use of the self -innovative drugs of the national pharmaceutical industry，The enthusiasm for promoting the independent innovation of national pharmaceutical industry drugs，Create a good independent innovation environment for my country's national pharmaceutical industry，Strategic guaranteeing my country ’s drug safety。
It can be seen from the history of global pharmaceutical development，The pharmaceutical industry has always been a high investment、High risk、High -produced fields。If there is not enough capital investment and policy encouragement，It will not promote the improvement of medical innovation capabilities。Independent innovation is the only way for my country to move from a major pharmaceutical country to a pharmaceutical country。Improving the ability to innovate in China ’s national pharmaceutical industry，is the basic guarantee for the health of the people in our country。
As a representative of the two sessions who understand the actual situation of the pharmaceutical industry，We hope that the government is standing at the strategic height of national drug safety，Pay attention to the status quo of the lack of innovation in the national pharmaceutical industry，Take strong measures as soon as possible，Increase the government's support for innovative pharmaceutical companies; further improve the drug registration approval policy，Build the "green channel" mechanism of innovative drugs; increase policy orientation of the transformation of the national pharmaceutical industry innovation drug market，Promote the health of my country's national pharmaceutical industry、Order、Quick Development。
