Heavy! Anhui supplies two votes system! December, very harsh

Pharmaceutical Network November 21 hearing following the implementation of supplies in Shaanxi Province nearly a year after the issue of an official in Anhui Province, the implementation of supplies two votes system! December 1 began.

The two product categories include: vascular intervention, non-vascular interventional, orthopedic surgery, neurosurgery, electrophysiology, pacemaker, cardiopulmonary bypass and blood purification, ophthalmic materials, dentistry, other Ten categories of high-value medical supplies.

Anhui is the country's first pilot province of medical reform, drug Two votes on the system it has been known for its harsh, supplies two tickets for action, no doubt it is cause for concern.

Comparison of two drugs system of documents, as well as two supplies of Shaanxi supplies system files and found that two supplies of consumables in Anhui is still very special, behind these special features, but also reflect what the problem?

First of all, Anhui supplies in the "two-vote system" on the definition, with the national drug version no difference: the domestic distributor of imported products counted one vote, the domestic enterprises without the exemption is also considered a national distributor, the circulation of the internal allocation is not a Votes ... everyone can not be too concerned about this.

In the implementation of the two-vote system requirements, such as votes, goods, accounts consistent, documents with the goods counterparts, etc., most of the same.

Now, the key is coming! What are the special places we look at:

First, the dispatch agencies are not the same. Drugs, the state is 8 ministries issued a document, including the State Council Office of Medical Reform, Health Planning Commission, Food and Drug Administration, Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Commerce, State Administration of Taxation, the state medicine Bureau.

However, Anhui is very different. The issuing units are Provincial Food and Drug Administration, Provincial Health and Planning Commission, Provincial Public Security Bureau, Provincial Trade and Industry Bureau, Provincial Internal Revenue Service.

Here, the medical reform office, development and reform, industrial and commercial letters, commerce, Chinese Medicine Bureau and other departments were omitted, and the public security and industrial and commercial departments were included in the document issuing authority. For the medical device enterprises, the above five units are greatly related of.

In the description of strengthening the supervision and inspection of the implementation of the two-vote system, Anhui proposed:

Public security organs shall, based on the convergence mechanism of the two laws, actively support the departments concerned to carry out the "two-vote system" of purchasing medical supplies and severely crack down on illegal and criminal activities such as the production and sale of medical consumables that do not meet the standards;

The tax authorities should strengthen the management of invoices of medical device manufacturing enterprises and medical institutions and increase the auditing of illegal acts such as falsification and tax evasion in accordance with the law.

The administrative department for industry and commerce shall severely crack down on monopolistic acts and unfair competition in the purchase and sale of medical consumables.

These policies are not the same as the two-vote system in other provinces. Obviously, the intensity of supervision will be much greater.

Second, the lead unit is different from the national version of the drug two votes, two supplies of Shaanxi supplies, led by the medical reform to do, and Anhui is the provincial food and Drug Administration.But with Anhui medicine two votes compared to lead units are Provincial Food and Drug Administration.

Drugs almost two votes, with the same people began to promote two supplies of consumables? In Anhui, two drugs on the market how the impact of the market, consumables will be the footsteps of the next?

Third, the scope of implementation is not the same .National version of the drug is not particularly clear, Shaanxi supplies two votes system is implemented to the county, township and village, but Anhui is not within the scope of administrative divisions, but requires more than two public hospitals must The implementation of two votes, followed by the hospital level go. Anhui Province two or more hospitals list, it seems to have become hot search.

Fourth, the two votes violate the "consequences" are not the same, Anhui is very serious.Anhui file pointed out that enterprises violate the two-vote system requirements, drug regulatory timely notification of the same level of health department; Ticket system of medical device manufacturing enterprises, public medical institutions, included in the bad record, according to the relevant provisions of the serious treatment, and evaluation and evaluation of medical institutions first, performance appraisal linked.

After the medical device manufacturing enterprises listed bad records, the bad records were collected to the business sector, which was uniformly recorded in the name of the enterprises by the business sector and publicized to the public through the enterprise credit information publicity system.

It can be said that two supplies of consumables in Anhui Province are quite harsh even if they are placed on the basis of the two-item medicine policy of all provinces in the country, and the violation of the two-vote system also includes the relevant investigation and handling of the aforementioned public security, industry and commerce and taxation.

It is understood that after two years of implementation of the two-vote system of pharmaceutical products in Anhui Province, 33 pharmaceutical wholesale enterprises in the province will not be able to meet the two-vote requirement because of their own business conditions. One after another, they voluntarily filed for the closure of their operations. At the same time, more than 10 conglomerate enterprises inside and outside the province took part in the merger Reorganization.

It is foreseeable that Anhui medical consumables distribution and delivery area, is about to usher in the era of major reshuffle, up to two votes system requirements, will be eliminated.

In order to implement the spirit of "Notice of the General Office of Anhui Provincial People's Government on Printing and Distributing the Key Tasks of Pilot Deepening the Pilot Reform Project of Pharmaceutical and Health System in 2017 in Anhui Province" (Wanzheng Office Secret [2017] No. 92), promote the public medical institutions in the province Consumables (included in the medical device management, the same below) the procurement of "two votes system" to develop the implementation of this opinion.

In-depth implementation of the CPC Central Committee and the State Council and the provincial government on deepening the reform of medical and health system, major decisions and arrangements in order to implement the procurement of medical consumables 'two-vote system' as the starting point to further promote the reform of medical device distribution, reduce intermediate links, Reduce the price of virtual high, effectively curb and crack down on the illegal acts of buying and selling medical consumables, safeguard the fundamental interests of the people, and ensure the safety of public use of machinery.

Medical consumables 'two-vote system' refers to the medical device manufacturers to the operating companies issued an invoice, the operating companies to the medical institutions issued an invoice.

A wholly-owned or controlled enterprise (only one in the country) that is solely owned by a medical device manufacturing enterprise or a group-type enterprise integrating science, industry and trade and selling only medical consumables of the enterprise (group) can be visualized as a manufacturer.

Imported medical supplies domestic total proxy (Only one for each major category in the country) Visible with the production enterprises.

Disposal of medical consumables within a wholly owned (holding) subsidiary or a wholly-owned (holding) subsidiary in a circulating conglomerate may not be considered as a vote, but a maximum of one invoice is permitted.

Medical consumables production and business enterprises in accordance with the principles of fairness, lawfulness and good faith to reasonably determine the level of fare increases.

(1) From December 1, 2017, the procurement of medical consumables shall be implemented in "two-vote system" in public medical institutions above the second-class in the province.

(B) the implementation of medical consumables 'two-vote system' for the centralized procurement platform for pharmaceuticals in Anhui Province public medical institutions high-value medical consumables online catalog purchase varieties, and gradually expand the scope of implementation.

Categories include: vascular interventional class, non-vascular interventional class, orthopedic surgery, neurosurgery, electrophysiology, pacemaker, cardiopulmonary bypass and blood purification, ophthalmic materials, dentistry, other top ten categories of high-value medical supplies .

(one) medical instruments Production, management enterprise When selling medical consumables, VAT invoices or VAT general invoices (hereinafter referred to as 'invoices') shall be issued in accordance with the relevant provisions of the invoice management and the items to be completed shall be filled in. The medical consumables to be sold shall also be sold in accordance with the regulations of the medical device manufacturing and operation quality management standards Requirements accompanied by compliance with the accompanying single with the invoice; invoice (and list, the same below) the purchase and sale of the name of the seller should be with the goods counterparts single, payment flow to the same amount.

(2) Medical device manufacturers may directly distribute medical consumables to public medical institutions above level 2 or may entrust medical device distribution companies to encourage the 'one-vote system' to support direct settlement between medical device manufacturers and public medical institutions Medical consumables payment, medical device manufacturers and medical device operators only settlement delivery costs between, and in accordance with the provisions of the invoice.

(3) The medical device management enterprise shall establish and implement the system for checking and recording the purchase of medical consumables. When the goods arrive for acceptance, the invoice shall be verified and the type, specification and model number, production lot number and quantity of medical consumables Etc., check the same and establish a purchase acceptance record.Medical consumables purchase and sales invoices and related records, should be kept in accordance with the relevant provisions.

(D) medical equipment distribution business medical supplies to medical institutions, medical equipment must be equipped with medical consumables to adapt to the professional guidance, technical training and after-sales service capabilities, or agreed by the relevant agencies to provide technical support.

(E) two or more public medical institutions purchasing medical consumables, the procurement contract must be clear 'two votes system' of the relevant requirements and agreed delivery specific issues and medical consumables quality and safety responsibilities and other related requirements to ensure that medical consumables can be timely delivery In place. Encourage medical supplies 'two votes system' and medical supplies centralized bidding, with the amount of procurement of organic convergence.

(F) public medical institutions above the second level from the purchase of medical supplies consumables, warehousing acceptance of the purchase of medical consumables should be examined and issued to the operating companies to obtain a copy of the sales invoice (including list) manufacturers (stamped with operating companies Seal of the original seal, each medical consumable varieties of the invoice for a copy of the purchase of at least once), two invoices operating company name, product name, model specifications, production lot number and other related content to verify each other, so that votes, goods, accounts of the three In line with the storage, use; the above invoices as public medical institutions to pay medical consumables vouchers, into the financial records management.

Encourage the use of electronic invoices in qualified areas and verify the 'two-vote system' by means of informatization so that bills can be traced back all the time.Medical institutions directly purchase medical consumables from manufacturing enterprises and should obtain the sales invoices and accompanying merchants' drafts in accordance with relevant regulations.

(VII) In order to cope with the special cases of natural disasters, major epidemics, major emergencies and patient emergency (grab) rescues, the medical consumables procured urgently may be specially handled.

(8) A wholly-owned or controlled medical device manufacturer established by a manufacturer of medical consumables shall provide the provincial Food and Drug Administration with relevant qualification documents of production and operation enterprises, catalogs of production and operation of medical consumables, power of attorney and promises of legal persons, etc. ;

The domestic distributor of imported medical consumables shall provide the provincial food and drug administration with the relevant qualification certificates of the medical device management enterprises and enter into agreements with domestic medical consumables for sales agents with foreign medical consumables manufacturers, import medical device registration certificates, customs clearance certificates and legal person authorization Power of attorney, commitment and other information;

The circulating group-type enterprises shall provide the Provincial Food and Drug Administration with the list of wholly-owned (holding) subsidiaries established, the relevant qualification certificates and commitments of the medical device operation enterprises, and other materials.

The Provincial Food and Drug Administration publishes the above information on its portal website and establishes a link with the provincial centralized purchasing platform for medical records for inspection by public medical institutions above the second class level.

(I) In the initial stage of the implementation of this Opinion, medical equipment consumables that can not be supplied by the original distribution enterprise in time according to the "two-vote system" may be negotiated by the medical institutions above the second grade for temporary distribution (in principle, no more than 3 months) After being supervised by the department in charge of health and family planning, it will be reported to the provincial pharmaceutical centralized purchasing platform to ensure the smooth supply of medical consumables.

(10) If the state has new regulations on the "two-vote system" of medical consumables, it shall be implemented in accordance with the relevant provisions of the state.

(1) The provincial Food and Drug Administration and Provincial Health and Family Planning Commission and other departments are responsible for supervising and guiding the implementation of the "two-vote system" of medical consumables in the whole province according to the implementation opinions; the food and drug supervision and management and health planning of all counties (cities and districts) And other departments responsible for the medical supplies within the administrative region 'two votes system' supervision and administration.

(2) The food and drug supervision and administration department shall step up the supervision and administration of medical consumables production and operation enterprises, incorporate the implementation of the 'two-vote system' by the enterprises into the scope of inspection, and severely crack down on all kinds of illegal and irregular behaviors; and violate the 'two-vote system 'Requirements, promptly notify the same level of health and family planning departments.

(C) Health and family planning departments should supervise the implementation of public health institutions more than two 'two votes system', not to implement medical supplies 'two votes system' of medical device manufacturing enterprises, public medical institutions, included in poor records, according to the relevant provisions Seriously dealt with, and with the medical institutions first evaluation, performance appraisal linked.

Medical equipment manufacturing enterprises included in the bad record, in accordance with the "government departments involved in the information unified collection publicity work plan," the request will be bad records collected to the business sector, the business sector unified record in the name of the enterprise, and through the enterprise Credit information publicity system to the public.

(4) The public security organ shall, based on the convergence mechanism of the two laws, actively support the relevant departments in carrying out the "two-vote system" of procurement of medical consumables and severely crack down on criminal activities such as manufacturing and selling non-standard medical consumables;

Tax authorities should strengthen the management of invoices for medical device manufacturing enterprises and medical institutions and step up auditing of such illegal acts as fraud and tax evasion in accordance with the law. The administrative departments for industry and commerce should severely crack down on monopolistic acts and unfair competition in the purchase and sale of medical consumables .

(A) attach great importance to the province's second-tier public medical institutions to implement the procurement of medical supplies 'two votes system' is our province deepen the reform of the medical and health system an important measure, all localities and departments should actively implement the 'two-vote system' Create favorable conditions, speed up the clean-up and repeal the unreasonable policies and regulations in the procurement of medical consumables and the selection of distributors, and ensure the smooth implementation of the "two-vote system".

(2) Strengthen publicity All localities and departments should widely publicize the purpose, practice and significance of the "two-vote system" of procurement of medical consumables through various media and actively respond to the social concerns and guide the production and operation of medical devices and enterprises above Grade II Public medical institutions to actively adapt to medical supplies 'two-vote system,' the new rules and new requirements.

(C) closely.Food and drug supervision at all levels, health and family planning, public security, industry and commerce, taxation and other departments should strengthen communication and coordination, clear division of responsibilities, good regulatory convergence, the formation of the work force.To combine some medical supplies market supply And the actual demand, coordinate medical consumables 'two-vote system' and medical supplies centralized bidding, with the amount of procurement relationship, to ensure the normal supply of clinical medical supplies.

(D) strict examination All localities and departments should promote the procurement of medical consumables 'two-vote system' into the medical reform performance evaluation important content, effectively promote the 'two-vote system' full implementation of the work.