Heavyweight file in Anhui, 265 hospitals to change!

Pharmaceutical Network November 21 News Anhui supplies 'two votes system', 265 hospitals, 10 days after the start of implementation!

November 20, Anhui Province Food and Drug Administration official website announced the "public medical institutions in Anhui Province procurement of medical supplies' two votes system implementation opinions (for Trial Implementation)" (hereinafter referred to). The document by the Anhui Food and Drug Administration, Wei Planning Commission, Public Security Department, Trade and Industry Bureau, State Administration of Taxation jointly issued (see the full text attached)

"Opinion" said the implementation of medical consumables 'two-vote system' of the species for the centralized procurement platform for medical centers in Anhui Province high-value medical consumables centralized catalog procurement catalog 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 .

"Opinions" made clear, from December 1, 2017 onwards, the implementation of medical supplies in two or more public medical institutions in Anhui Province 'two-vote system.' It should be said that, according to the previous multi-provincial documents on the 'two The above public medical institutions, 'the universal point of access to experience and judgment, as described in Anhui "Opinions," should include the two medical institutions.

According to the statistics of the State Health Planning Commission Database, there are 185 medical institutions above Grade II in Anhui Province. According to incomplete statistics, there are about 80 hospitals in Anhui Province with secondary or higher levels.

However, this document also shows that in the initial implementation of the Opinions, medical institutions that are not allowed to supply medical supplies in time according to the "two-vote system" requirement can be negotiated by medical institutions above the second tier for setting up a temporary distribution relationship (in principle, More than 3 months).

Basically, followed by the right drug 'Two-vote system' defined the principle.

The Opinion shows that a wholly-owned or holding enterprise (only one in the country) that is solely owned by a medical device manufacturer 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 consumables domestic distributor (each major category of the country only one) with the visual manufacturing 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.

At the provincial level to implement supplies 'two-vote system', Anhui is the third before this, Shaanxi, Qinghai hair push 'two-vote system', a spoonful of medicines and consumables.Also there are prefecture-level cities and 'Sanming Union' implementation supplies 'two votes system'.

Anhui medicine 'two-vote system' started earlier in the October 8, 2016 issued a document, the year of November 1 began in the year after the implementation of drugs, medical supplies in the copy, according to this logical corollary, the National Supplies 'Two-vote system' is inevitable.

With the implementation of the "two-vote system" of medicine, the current observation is that for the industry, the workload has become huge, requiring both large-area distribution of commercial accounts and great efforts to resolve financial pressures after opening and commissions. In addition to In addition, it seems not too much troubled.

It touches on the big business, such as the top 100 pharmaceutical companies, like a duck in water, borrowing the "two-vote system" to infiltrate the state of Shenzhou and taking advantage of policies to encourage mergers and acquisitions to expand rapidly.

The worst thing is to get a proxy, and then again Merchants Of these people, can not eat 'patchwork', and its affiliated small business company, bear the brunt of the words of an industry friend 'such companies and teams have an extinct trend!

In order to implement "General Office of Anhui Provincial People's Government on the issuance of Anhui Province in 2017 to deepen medicine Notice on Key Tasks of Comprehensive Pilot Reform of Health System "(Wanzheng Office Secret [2017] No. 92) and promote the implementation of the" two-vote system "in the procurement of medical consumables (included in the management of medical devices, the same below) of the province's public medical institutions. , Formulate 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, compression of the 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.

(II) The implementation of medical consumable 'two-vote system' is the centralized procurement catalog catalog of high-value medical consumables for public medical institutions in Anhui Medical centralized purchasing platform, and gradually expands the scope of its implementation. The scope of categories includes: vascular intervention, non-vascular intervention Class, orthopedic implants, neurosurgery, electrophysiology, pacemakers, cardiopulmonary bypass and blood purification, ophthalmic materials, dentistry, and other top-10 high-value medical supplies.

(one) medical instruments When producing and selling medical consumables, the enterprises shall issue special VAT invoices or general VAT invoices (hereinafter referred to as 'invoices') in accordance with the relevant provisions of the invoice management and complete the items to be filled in. The medical consumables to be sold shall also be sold in accordance with the medical device manufacturing and operation The requirements of the quality management standard shall be accompanied by the accompanying documents accompanying the stipulations; the name of the purchaser and the seller of the invoice (as well as the list below) shall be the same as that of the counterparts in the goods with the same payment flow.

(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, they shall verify the invoice, the type of medical consumables and specifications 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 to obtain business from the production company sales invoices (including a list) copy (with a business 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 The invoice as public medical institutions to pay medical consumables vouchers, into the financial records management.Encourage the use of electronic invoices in areas where the conditions permit, through the means of information verification 'two-vote system' to achieve the entire bill traceable Medical institutions directly from the manufacturing enterprises to purchase medical supplies should be required in accordance with the provisions of the company sales invoices and accompanying merchandise list.

(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. ; Imported medical consumables domestic distributor shall provide the provincial food and drug administration medical equipment business enterprise qualification certificates, and foreign medical consumables manufacturers entered into the domestic medical consumables sales agency agreement, import medical equipment registration certificate, customs clearance certificate, legal person Power of attorney, commitment and other information; the circulation of group-type enterprises should be provided to the provincial Food and Drug Administration set up a wholly-owned (holding) list of subsidiaries, medical equipment business credentials and other relevant documents, undertakings and other information. The EAA publishes the above information on its portal website and establishes a link with the provincial pharmaceutical centralized purchasing platform for reference for public medical institutions above Grade 2 or above.

(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) Other departments are responsible for the supervision and management of medical consumables 'two-vote system' within their respective administrative regions.

(2) The food and drug supervision and administration department shall step up the supervision and administration of medical consumables production and operation enterprises, include the implementation of the 'two-vote system' by the enterprises in 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 deal with, and with the medical institutions first evaluation, performance appraisal linked.A medical device manufacturing enterprises included in the bad record, in accordance with the "government departments involved in the information unified collection publicity work plan" requirement, the bad records collected The business sector, unified by the business sector under the name of enterprises, and through corporate 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 purchasing medical consumables and severely crack down on the production and sale of medical consumables that do not meet the standards, and the tax authorities shall step up their efforts in the medical equipment Production and operation of enterprises and medical institutions invoice management, according to the law increase fake, tax evasion and other illegal inspection efforts; business administration departments to crack down on medical consumables purchase and sale of monopolistic behavior and unfair competition behavior.

(A) attach great importance to the province's second-tier public medical institutions to implement medical supplies procurement '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 consumables centralized bidding, with the amount of procurement relationship, to ensure the normal supply of medical consumables clinical.

(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.