Industry News
Two votes nine full focus on the interpretation of medical equipment to see the first look!
January 9, the State Council Medical Reform Office "on the implementation of public medical institutions in the procurement of drugs" two votes system "implementation of the views (Trial)" (hereinafter referred to as "two votes") officially announced.
The document by the State Council Medical Reform Leading Group, the State Health Commission, Drug Administration, Development and Reform Commission, Ministry of Industry, Ministry of Commerce, the State Administration of Taxation, Chinese Medicine Bureau of the eight agencies jointly issued by the 8 will be jointly implemented. Combined with the document and the Health Commission issued an official interpretation of the conference, cyber blue for your analysis and interpretation of the "two votes" of the seven core issues to readers.
▍ core question one: "two votes system" to do?
The final official version of the two votes will be located in the "deepening of health care reform, promote the healthy development of the pharmaceutical industry an important measure", "is to regulate the order of drug circulation, compression circulation, reduce the price of virtual high important starting point", and " Circulation environment, to combat 'money laundering money', strengthen the pharmaceutical market regulation effective means. In recent years, the whole society for the medical burden of the call is getting higher and higher, the final problem brought together into the public most familiar with the six words "difficult to see a doctor", "expensive".
On the other side, over the years, China's drug distribution areas, "how small scattered bad" situation has not been fundamentally changed, the drug circulation chain long, chaotic circulation, linked to business, money swip money, buy short, gold sales, pushing the drug price. These problems also exist in the medical device industry. In this context, through the "two-vote system," the financial means to deal with the ills of the pharmaceutical industry, as civil and regulatory common common entrance and choice.
▍ core question two: "two votes" how to set?
The national version of the final "votes" that is, "pharmaceutical manufacturers to the circulation enterprises to open an invoice, circulation enterprises to the medical institutions to open an invoice." Among them, the pharmaceutical production enterprises or industry and trade integration of the group-type enterprises set up only Sales of the enterprise (group) drugs wholly-owned or holding commercial companies, foreign pharmaceutical domestic distributor can be regarded as the production enterprises, but the country is limited to a commercial company, a domestic distributor, and the fare to be controlled within a certain range.
Particularly worthy of note is that the transfer of pharmaceuticals within a pharmaceutical distribution group within a wholly-owned (controlled) subsidiary or a wholly-owned (controlled) subsidiary is not considered as a single vote, but a maximum of one invoice is allowed, and the increase is subject to control Within a certain range, the specific rate of increase by the provinces (autonomous regions and municipalities) regulations. Encourage public medical institutions and drug manufacturers to directly settle the payment of drugs, pharmaceutical production enterprises and distribution enterprises settlement and distribution costs.
The above is the national version of the two rules of the system. Conversion to the future may be the introduction of the medical supplies of the national version of the two votes on the system, from Shaanxi and other provinces to push the two tickets to the point of view, the "two votes" should be the same as the definition of drugs.
▍ core question three: what circumstances can not "two votes system"?
The national version stipulates that the drug distribution enterprises will be allowed to re-open the purchase and sale invoice on the basis of the "two-vote system" when the drug is distributed to the township (town) and village medical and health institutions with special remote and inconvenient transportation. This is to protect the effective supply of primary drugs, but also allowed only three votes, put an end to four votes, and strictly limited to a small number of township hospitals and village health room, the mouth is not torn.
In addition, the document also provides that in response to natural disasters, major epidemics, major emergencies and patients with emergency (robbing) to save and other special circumstances, emergency procurement of drugs or national pharmaceutical reserves of drugs, special treatment. The circulation of narcotic drugs and the first category of psychotropic drugs is not subject to the implementation of the two-vote system. The above exemptions, the future or analogy to the field of supplies, such as Shaanxi Province, "the clinical use of technical support requirements of high special high-value medical supplies" temporarily not to implement the two-vote system, and high-value supplies first two votes, To the general medical supplies.
▍ core question four: "two votes system" in what scope of implementation?
The national version stipulates that the implementation of the "two-vote system" in the procurement of pharmaceuticals in public medical institutions encourages other medical institutions to implement the "two-vote system". Social forces, such as private hospitals can be exempted. In addition, public medical institutions are to be implemented step by step. In 2017, 11 pilot hospitals and 200 public hospital reform pilot cities took the lead in implementing the two-vote system, encouraging other regions to implement two-vote system; in 2018, for the promotion of the two votes throughout the country.
(Picture from Hua Zhao equipment network, has been authorized to reprint)
Medical reform pilot provinces and pilot cities to implement the first two, the supply of two votes should also be the case. In fact, the current clearly put forward in 2017 on the implementation of supplies two votes in the region, are also medical reform pilot provinces or pilot cities. In addition, because the drug two votes system is gradually pushed to 2018 only cover the country. Also means that the two-vote system of goods to promote the country, the time will be later, the industry also left a certain time to learn in advance, change.
Core Question 5: How should enterprises and medical institutions implement the "two-vote system"?
A: The state documents, pharmaceutical production, circulation enterprises selling drugs, should be in accordance with the relevant provisions of the invoice issued VAT invoices or ordinary invoices, the project should be completed complete. The sales of drugs should also be in accordance with the requirements of the drug quality management practices (GSP) requirements with the provisions of the accompanying goods with the single, invoice purchase, the seller name should be with the goods with the single, payment flow consistent, the same amount.
Drug distribution enterprises to purchase drugs, should take the initiative to the pharmaceutical production enterprises to ask for invoices, invoices must be issued by the pharmaceutical production enterprises. Acceptance of goods, should verify the invoice, the supplier with the goods with the actual purchase of drugs with the actual variety, specifications, quantity, etc., check the same and the establishment of purchase of drug acceptance records, so that tickets, goods, accounts match. The invoice and the accompanying counterparts do not meet the relevant requirements of the state, or the contents of the votes, the contents of the goods do not match, not acceptance. In addition, encourage the elimination of local protection and support large-scale enterprises to build a national, regional drug logistics park and distribution center, allowing multi-warehouse collaborative distribution, allowing pharmaceutical companies to establish different positions in the province, cross-regional use of the enterprise eligible drugs Warehouse, etc., but do not billing.
As for public medical institutions, in the drug acceptance of storage must be verified tickets, goods, accounts of the three can be unified, use. Public medical institutions not only to the distribution of pharmaceutical companies to request, verify the invoice, should also require the circulation of enterprises issued by the original seal issued by the manufacturer to provide a copy of the purchase invoice, two invoices of drug distribution company name, drug batch number, etc. Related content confirmed each other, and as a public medical institutions to pay drug payment vouchers, into the financial file management. A copy of the purchase invoice for each drug variety is provided at least once. Encourage qualified areas to use electronic invoices, through information technology to verify the "two votes system." The above invoice management and inspection measures, or will be directly transplanted to the field of supplies.
▍ Core Question 6: How will a business violate the "two-vote system"?
"Notice" clear requirements, since January 9, it should be in accordance with the implementation of the two votes, all localities and departments to linkage, to achieve illegal clues to the Internet, to deal with the results of mutual recognition. The relevant departments of the state will also organize two votes to implement the special inspection. Provinces (autonomous regions and municipalities) centralized purchasing agencies in the production of tender documents, the two votes should be made as a prerequisite for enterprises, from the source to check. The implementation of the "two votes" requirements of the pharmaceutical production, circulation enterprises, cancel the tender, the successful bidder and distribution qualifications, and included in the drug procurement bad record.
Drug Administration departments will implement the implementation of the two votes in the regulatory system, in the daily inspection, follow-up inspection, flight inspection, the drug circulation of goods, accounts, tickets, models, the consistency of the certificate, as the focus of inspection. Found the problem, to the local provincial recruitment department to inform the situation; suspected of violation of drugs GMP, GSP relevant provisions, according to the law severely punished and exposed; suspected of crime, transferred to the public security organs.
The tax department will strengthen the pharmaceutical production, circulation enterprises and medical institutions invoice management, according to the law to increase the inspection of tax evasion efforts. Tax on January 1 this year has launched a national value-added tax invoice inspection platform, units and individuals can check the invoice full-vote information, timely detection of false invoices. Health care and Chinese medicine administrative departments will strengthen the supervision and inspection of the implementation of the two-vote system of medical institutions, the ticket (card) is not strict, the two-vote system is not in place, arrears of money, there is no medical institutions to inform criticism Hold the responsibility of the relevant personnel.
▍ core question seven: two votes system will have any impact on the flow of medicine?
The impact of small and medium business, good big business, two votes in the field of circulation must be staged "side is the side of the sea is the flame." Public data show that China has a total of more than 13,000 drug wholesale license of the circulation enterprises, annual sales of more than 50 million yuan of enterprises less than 5%, the concentration and the developed countries compared to the gap between the poor. In accordance with the policy design, "two-vote system" after the implementation of some enterprises in the past through the votes of commercial companies to complete the capital cost of the cycle was basically broken, so long for the company to survive the space was compressed, In May this year, the implementation of the "battalion" tax reform policy, a large number of survival by the votes of commercial companies in these combination policy, the original value of the loss, facing out, the number of circulation enterprises will be a substantial reduction in the number of policies.
And the "two-vote" national documents in the provisions of the drug distribution group-owned enterprises and wholly-owned (holding) subsidiaries or wholly-owned (holding) subsidiaries between the transfer of drugs can not be regarded as a vote, will be clear and good group-type drug distribution enterprises At the same time with the implementation of the policy in depth, a large number of agency-based pharmaceutical companies, small and medium-sized pharmaceutical business company is bound to need to transition or seek to be mergers, large pharmaceutical circulation enterprises will further accelerate the merger and reorganization of the release opportunity to further improve drug distribution concentration.
There are circulation experts on this issue further said that a series of domino effect will be rapid - "two votes system" will break the laws of the circulation of the pharmaceutical market, to some extent the industry will increase the cost; a large number of agents of commercial out; Distribution business companies usher in the development opportunities, you can direct supply terminal; and large-scale pharmaceutical business will quickly lay the prefecture-level network to seize the market, the reserve price of industrial enterprises face challenges, high open high or self-network enterprises are facing opportunities The commercial company that survives the bill will be eliminated because of the loss of its original value.
Core Question 8: How will the two-vote system change the pharmaceutical industry?
With the "two votes system" to run, different types of pharmaceutical industry will face different changes in the living environment, it is several happy several worry. For public hospitals as the main target market enterprises, the reserve price agency investment marketing model will be the greatest impact, and high open high and self-help team will usher in more opportunities. And this policy will be less impact to the hospital prescription market and the third terminal, OTC retail market and private health care will also usher in a good market adjustment opportunities.
But the industry will also face some problems, such as the difficulty of taxation to increase, at the same time, increased sales costs, lower profit margins; marketing management more difficult, such as a substantial increase in the number of distribution business, channel management more difficult; Coexistence, financial processing more difficult; third terminal distribution business choice problems; business return cycle changes: short-term may be shortened, long-term will become an extension of the trend, need to adapt to their own situation in a timely manner to adapt.
▍ core problem nine: two votes system + increase + circulation rectification, agents where the way out?
Two votes system, battalion increase, circulation remediation and a series of policy under the boxing, the national total agent may gradually disappear. With the increase in operating costs, lower profit margins, professional academic promotion agents will be more and more favored, hospital-level commission agents to thrive, and channel control weakened (no self-market, do not have the ability to send GSP institutions Agents advantage gone), the national total agents (except for import agents) or will gradually disappear. On this topic, the industry veteran experts to the Cypriot Blue said that the current industry, many people on the relevant state departments of the policy misunderstanding, or understand some one-sided, once the empathy, standing on the perspective of the relevant government departments to look at the industry, The idea point of view will be very different.
He believes that in fact, regulators can not wish to deliberately suppress which industry, they hope that the healthy development of the industry, the real benefits for the people, therefore, in the introduction of these policies, it is certainly hope that the purification of the industry environment, promote the healthy development of industry , Of course, do not rule out the authorities because of the policy effect is too expected, too urgent, or other factors may have some extreme places, may cause "accidental injury" to the enterprise. "The government's consideration, many times the industry can not understand, then the government in many cases, for many considerations, it is inconvenient to open communication to the industry, so there is a misunderstanding." He said.
Two versions of the drug system has been officially announced! And not an accident, the future of the instrument two votes will be the main reference to two drugs to define the system and the implementation of the difference will not be large.
The document by the State Council Medical Reform Leading Group, the State Health Commission, Drug Administration, Development and Reform Commission, Ministry of Industry, Ministry of Commerce, the State Administration of Taxation, Chinese Medicine Bureau of the eight agencies jointly issued by the 8 will be jointly implemented. Combined with the document and the Health Commission issued an official interpretation of the conference, cyber blue for your analysis and interpretation of the "two votes" of the seven core issues to readers.
▍ core question one: "two votes system" to do?
The final official version of the two votes will be located in the "deepening of health care reform, promote the healthy development of the pharmaceutical industry an important measure", "is to regulate the order of drug circulation, compression circulation, reduce the price of virtual high important starting point", and " Circulation environment, to combat 'money laundering money', strengthen the pharmaceutical market regulation effective means. In recent years, the whole society for the medical burden of the call is getting higher and higher, the final problem brought together into the public most familiar with the six words "difficult to see a doctor", "expensive".
On the other side, over the years, China's drug distribution areas, "how small scattered bad" situation has not been fundamentally changed, the drug circulation chain long, chaotic circulation, linked to business, money swip money, buy short, gold sales, pushing the drug price. These problems also exist in the medical device industry. In this context, through the "two-vote system," the financial means to deal with the ills of the pharmaceutical industry, as civil and regulatory common common entrance and choice.
▍ core question two: "two votes" how to set?
The national version of the final "votes" that is, "pharmaceutical manufacturers to the circulation enterprises to open an invoice, circulation enterprises to the medical institutions to open an invoice." Among them, the pharmaceutical production enterprises or industry and trade integration of the group-type enterprises set up only Sales of the enterprise (group) drugs wholly-owned or holding commercial companies, foreign pharmaceutical domestic distributor can be regarded as the production enterprises, but the country is limited to a commercial company, a domestic distributor, and the fare to be controlled within a certain range.
Particularly worthy of note is that the transfer of pharmaceuticals within a pharmaceutical distribution group within a wholly-owned (controlled) subsidiary or a wholly-owned (controlled) subsidiary is not considered as a single vote, but a maximum of one invoice is allowed, and the increase is subject to control Within a certain range, the specific rate of increase by the provinces (autonomous regions and municipalities) regulations. Encourage public medical institutions and drug manufacturers to directly settle the payment of drugs, pharmaceutical production enterprises and distribution enterprises settlement and distribution costs.
The above is the national version of the two rules of the system. Conversion to the future may be the introduction of the medical supplies of the national version of the two votes on the system, from Shaanxi and other provinces to push the two tickets to the point of view, the "two votes" should be the same as the definition of drugs.
▍ core question three: what circumstances can not "two votes system"?
The national version stipulates that the drug distribution enterprises will be allowed to re-open the purchase and sale invoice on the basis of the "two-vote system" when the drug is distributed to the township (town) and village medical and health institutions with special remote and inconvenient transportation. This is to protect the effective supply of primary drugs, but also allowed only three votes, put an end to four votes, and strictly limited to a small number of township hospitals and village health room, the mouth is not torn.
In addition, the document also provides that in response to natural disasters, major epidemics, major emergencies and patients with emergency (robbing) to save and other special circumstances, emergency procurement of drugs or national pharmaceutical reserves of drugs, special treatment. The circulation of narcotic drugs and the first category of psychotropic drugs is not subject to the implementation of the two-vote system. The above exemptions, the future or analogy to the field of supplies, such as Shaanxi Province, "the clinical use of technical support requirements of high special high-value medical supplies" temporarily not to implement the two-vote system, and high-value supplies first two votes, To the general medical supplies.
▍ core question four: "two votes system" in what scope of implementation?
The national version stipulates that the implementation of the "two-vote system" in the procurement of pharmaceuticals in public medical institutions encourages other medical institutions to implement the "two-vote system". Social forces, such as private hospitals can be exempted. In addition, public medical institutions are to be implemented step by step. In 2017, 11 pilot hospitals and 200 public hospital reform pilot cities took the lead in implementing the two-vote system, encouraging other regions to implement two-vote system; in 2018, for the promotion of the two votes throughout the country.
(Picture from Hua Zhao equipment network, has been authorized to reprint)
Medical reform pilot provinces and pilot cities to implement the first two, the supply of two votes should also be the case. In fact, the current clearly put forward in 2017 on the implementation of supplies two votes in the region, are also medical reform pilot provinces or pilot cities. In addition, because the drug two votes system is gradually pushed to 2018 only cover the country. Also means that the two-vote system of goods to promote the country, the time will be later, the industry also left a certain time to learn in advance, change.
Core Question 5: How should enterprises and medical institutions implement the "two-vote system"?
A: The state documents, pharmaceutical production, circulation enterprises selling drugs, should be in accordance with the relevant provisions of the invoice issued VAT invoices or ordinary invoices, the project should be completed complete. The sales of drugs should also be in accordance with the requirements of the drug quality management practices (GSP) requirements with the provisions of the accompanying goods with the single, invoice purchase, the seller name should be with the goods with the single, payment flow consistent, the same amount.
Drug distribution enterprises to purchase drugs, should take the initiative to the pharmaceutical production enterprises to ask for invoices, invoices must be issued by the pharmaceutical production enterprises. Acceptance of goods, should verify the invoice, the supplier with the goods with the actual purchase of drugs with the actual variety, specifications, quantity, etc., check the same and the establishment of purchase of drug acceptance records, so that tickets, goods, accounts match. The invoice and the accompanying counterparts do not meet the relevant requirements of the state, or the contents of the votes, the contents of the goods do not match, not acceptance. In addition, encourage the elimination of local protection and support large-scale enterprises to build a national, regional drug logistics park and distribution center, allowing multi-warehouse collaborative distribution, allowing pharmaceutical companies to establish different positions in the province, cross-regional use of the enterprise eligible drugs Warehouse, etc., but do not billing.
As for public medical institutions, in the drug acceptance of storage must be verified tickets, goods, accounts of the three can be unified, use. Public medical institutions not only to the distribution of pharmaceutical companies to request, verify the invoice, should also require the circulation of enterprises issued by the original seal issued by the manufacturer to provide a copy of the purchase invoice, two invoices of drug distribution company name, drug batch number, etc. Related content confirmed each other, and as a public medical institutions to pay drug payment vouchers, into the financial file management. A copy of the purchase invoice for each drug variety is provided at least once. Encourage qualified areas to use electronic invoices, through information technology to verify the "two votes system." The above invoice management and inspection measures, or will be directly transplanted to the field of supplies.
▍ Core Question 6: How will a business violate the "two-vote system"?
"Notice" clear requirements, since January 9, it should be in accordance with the implementation of the two votes, all localities and departments to linkage, to achieve illegal clues to the Internet, to deal with the results of mutual recognition. The relevant departments of the state will also organize two votes to implement the special inspection. Provinces (autonomous regions and municipalities) centralized purchasing agencies in the production of tender documents, the two votes should be made as a prerequisite for enterprises, from the source to check. The implementation of the "two votes" requirements of the pharmaceutical production, circulation enterprises, cancel the tender, the successful bidder and distribution qualifications, and included in the drug procurement bad record.
Drug Administration departments will implement the implementation of the two votes in the regulatory system, in the daily inspection, follow-up inspection, flight inspection, the drug circulation of goods, accounts, tickets, models, the consistency of the certificate, as the focus of inspection. Found the problem, to the local provincial recruitment department to inform the situation; suspected of violation of drugs GMP, GSP relevant provisions, according to the law severely punished and exposed; suspected of crime, transferred to the public security organs.
The tax department will strengthen the pharmaceutical production, circulation enterprises and medical institutions invoice management, according to the law to increase the inspection of tax evasion efforts. Tax on January 1 this year has launched a national value-added tax invoice inspection platform, units and individuals can check the invoice full-vote information, timely detection of false invoices. Health care and Chinese medicine administrative departments will strengthen the supervision and inspection of the implementation of the two-vote system of medical institutions, the ticket (card) is not strict, the two-vote system is not in place, arrears of money, there is no medical institutions to inform criticism Hold the responsibility of the relevant personnel.
▍ core question seven: two votes system will have any impact on the flow of medicine?
The impact of small and medium business, good big business, two votes in the field of circulation must be staged "side is the side of the sea is the flame." Public data show that China has a total of more than 13,000 drug wholesale license of the circulation enterprises, annual sales of more than 50 million yuan of enterprises less than 5%, the concentration and the developed countries compared to the gap between the poor. In accordance with the policy design, "two-vote system" after the implementation of some enterprises in the past through the votes of commercial companies to complete the capital cost of the cycle was basically broken, so long for the company to survive the space was compressed, In May this year, the implementation of the "battalion" tax reform policy, a large number of survival by the votes of commercial companies in these combination policy, the original value of the loss, facing out, the number of circulation enterprises will be a substantial reduction in the number of policies.
And the "two-vote" national documents in the provisions of the drug distribution group-owned enterprises and wholly-owned (holding) subsidiaries or wholly-owned (holding) subsidiaries between the transfer of drugs can not be regarded as a vote, will be clear and good group-type drug distribution enterprises At the same time with the implementation of the policy in depth, a large number of agency-based pharmaceutical companies, small and medium-sized pharmaceutical business company is bound to need to transition or seek to be mergers, large pharmaceutical circulation enterprises will further accelerate the merger and reorganization of the release opportunity to further improve drug distribution concentration.
There are circulation experts on this issue further said that a series of domino effect will be rapid - "two votes system" will break the laws of the circulation of the pharmaceutical market, to some extent the industry will increase the cost; a large number of agents of commercial out; Distribution business companies usher in the development opportunities, you can direct supply terminal; and large-scale pharmaceutical business will quickly lay the prefecture-level network to seize the market, the reserve price of industrial enterprises face challenges, high open high or self-network enterprises are facing opportunities The commercial company that survives the bill will be eliminated because of the loss of its original value.
Core Question 8: How will the two-vote system change the pharmaceutical industry?
With the "two votes system" to run, different types of pharmaceutical industry will face different changes in the living environment, it is several happy several worry. For public hospitals as the main target market enterprises, the reserve price agency investment marketing model will be the greatest impact, and high open high and self-help team will usher in more opportunities. And this policy will be less impact to the hospital prescription market and the third terminal, OTC retail market and private health care will also usher in a good market adjustment opportunities.
But the industry will also face some problems, such as the difficulty of taxation to increase, at the same time, increased sales costs, lower profit margins; marketing management more difficult, such as a substantial increase in the number of distribution business, channel management more difficult; Coexistence, financial processing more difficult; third terminal distribution business choice problems; business return cycle changes: short-term may be shortened, long-term will become an extension of the trend, need to adapt to their own situation in a timely manner to adapt.
▍ core problem nine: two votes system + increase + circulation rectification, agents where the way out?
Two votes system, battalion increase, circulation remediation and a series of policy under the boxing, the national total agent may gradually disappear. With the increase in operating costs, lower profit margins, professional academic promotion agents will be more and more favored, hospital-level commission agents to thrive, and channel control weakened (no self-market, do not have the ability to send GSP institutions Agents advantage gone), the national total agents (except for import agents) or will gradually disappear. On this topic, the industry veteran experts to the Cypriot Blue said that the current industry, many people on the relevant state departments of the policy misunderstanding, or understand some one-sided, once the empathy, standing on the perspective of the relevant government departments to look at the industry, The idea point of view will be very different.
He believes that in fact, regulators can not wish to deliberately suppress which industry, they hope that the healthy development of the industry, the real benefits for the people, therefore, in the introduction of these policies, it is certainly hope that the purification of the industry environment, promote the healthy development of industry , Of course, do not rule out the authorities because of the policy effect is too expected, too urgent, or other factors may have some extreme places, may cause "accidental injury" to the enterprise. "The government's consideration, many times the industry can not understand, then the government in many cases, for many considerations, it is inconvenient to open communication to the industry, so there is a misunderstanding." He said.
Two versions of the drug system has been officially announced! And not an accident, the future of the instrument two votes will be the main reference to two drugs to define the system and the implementation of the difference will not be large.
