銷售生物制品診斷試劑的醫(yī)療器械公司增值稅計稅方法
發(fā)布時間：
2022-11-16
作者：
銷售生物制品診斷試劑的醫(yī)療器械公司增值稅計稅方法
我們在對醫(yī)藥行業(yè)的日常咨詢、審計過程中，發(fā)現(xiàn)醫(yī)藥類行業(yè)中銷售生物制品醫(yī)療耗材-診斷試劑，而僅持有《醫(yī)療器械經(jīng)營許可證》的公司，不能按現(xiàn)行稅法制度中的規(guī)定選擇增值稅簡易計稅方法，從而增加該類公司增值稅稅負，增加相關納稅人負擔。
一、現(xiàn)行增值稅相關規(guī)定
1、《財政部國家稅務總局關于部分貨物適用增值稅低稅率和簡易辦法征收增值稅政策的通知》（財稅〔2009〕9號）第二條第（三）項第4目規(guī)定：“一般納稅人銷售用微生物、微生物代謝產(chǎn)物、動物毒素、人或動物的血液或組織制成的生物制品，可選擇按照簡易辦法依照6%征收率（現(xiàn)已改為3%征收率）計算繳納增值稅”。
2、《國家稅務總局關于藥品經(jīng)營企業(yè)銷售生物制品有關增值稅問題的公告》（國家稅務總局公告2012年第20號）第一條規(guī)定：“屬于增值稅一般納稅人的藥品經(jīng)營企業(yè)銷售生物制品，可以選擇簡易辦法按照生物制品銷售額和3%的征收率計算繳納增值稅。藥品經(jīng)營企業(yè)，是指取得（食品）藥品監(jiān)督管理部門頒發(fā)的《藥品經(jīng)營許可證》，獲準從事生物制品經(jīng)營的藥品批發(fā)企業(yè)和藥品零售企業(yè)”。
綜上規(guī)定，增值稅一般納稅人生產(chǎn)、銷售生物制品，可以選擇簡易辦法按照生物制品銷售額和3%的征收率計算繳納增值稅，但銷售企業(yè)必須取得（食品）藥品監(jiān)督管理部門頒發(fā)的《藥品經(jīng)營許可證》。
二、概念與應用
生物制品系指以微生物、寄生蟲、動物毒素、生物組織作為起始材料，采用生物學工藝或分離純化技術制備，并以生物學技術和分析技術控制中間產(chǎn)物和成品質量制成的生物活性制劑，包括菌苗，疫苗，毒素，類毒素，免疫血清，血液制品，免疫球蛋白，抗原，變態(tài)反應原，細胞因子，激素，酶，發(fā)酵產(chǎn)品，單克隆抗體，DNA重組產(chǎn)品，體外免疫診斷制品等。
生物制品的應用分預防、治療和診斷三個方面。
1、治療制品：包括各種血液制劑、免疫制劑如干擾素；
2、預防疫苗；
3、診斷制品：大都用于檢測相應抗原、抗體或機體免疫狀態(tài)，可分以下幾類：①體內試驗診斷制劑類。常用的有布魯斯氏菌素、結核菌素和錫克試驗毒素（白喉）三種。②一般傳染病的診斷制劑類。包括各種診斷菌液、病毒液和診斷血清。③診斷腫瘤用制劑。如甲胎蛋白血清、癌胚抗原診斷試劑盒等。④測定免疫水平的診斷制劑。測定人體內所含的五種免疫球蛋白，用于疾病診斷、治療以及機體免疫功能的測定，亦是臨床診斷某些疾病的重要指標。⑤激素用診斷制劑。如妊娠診斷制劑。
三、銷售生物制品醫(yī)療耗材-診斷試劑的醫(yī)療器械公司，增值稅選擇計稅方法時存在的困惑
目前，從事生物制品醫(yī)療耗材銷售的企業(yè)，所銷售的生物制品醫(yī)療耗材-診斷試劑，屬于生物制品中的診斷用制品，全部銷售給醫(yī)院檢驗科，但只能取得《醫(yī)療器械經(jīng)營許可證》。
因這部分生物制品被劃分為“體外診斷試劑”，食品藥品監(jiān)督管理部門按規(guī)定辦理《醫(yī)療器械經(jīng)營許可證》。食品藥品監(jiān)督管理部門批準的《醫(yī)療器械經(jīng)營許可證》的經(jīng)營范圍中，這類醫(yī)療耗材屬于：6840臨床檢驗分析儀器及診斷試劑。
根據(jù)現(xiàn)行增值稅的規(guī)定，未取得《藥品經(jīng)營許可證》的企業(yè)不能選擇簡易計稅方法，從而使這一類企業(yè)增值稅稅負增加。此類企業(yè)從生產(chǎn)企業(yè)采購生物制品診斷試劑時，因生產(chǎn)企業(yè)銷售自產(chǎn)的生物制品，可以選擇采用簡易計稅方法，按3%的征收率計稅，故此類企業(yè)取得的增值稅專用發(fā)票只能抵扣3%的增值稅進項稅額，而此類企業(yè)一般納稅人對外銷售診斷試劑時，增值稅稅率為17%（2018年5月1日后改為16%），實際稅負為14%，負擔很重。生產(chǎn)企業(yè)因生產(chǎn)此類生物制品，所采用的原材料實際操作中很難取得增值稅進項票，因此，多選擇采用簡易計稅方法，按3%的征收率計稅。
例：某公司為經(jīng)營醫(yī)療器械的銷售企業(yè)，取得《醫(yī)療器械經(jīng)營許可證》，90%的銷售系生物制品診斷試劑，全部銷售給各大醫(yī)院檢驗科。2017年銷售生物制品診斷試劑1000萬元（不含稅金額），從生產(chǎn)企業(yè)采購生物制品診斷試劑800萬元（不含稅金額），全部取得增值稅專用發(fā)票，稅率為3%（生產(chǎn)企業(yè)選擇簡易計稅方法），該公司收入進行了分別核算。假設該公司未取得其他事項的增值稅專用發(fā)票，無其他可抵扣進項稅額。
生物制品類銷售的銷項稅額=1000*17%=170萬元
進稅額=800*3%=24萬元
應納稅額=170-24=146萬元
實際稅負=146/1000=14.6%
四、解決辦法的思考
2016年營改增時，李克強總理提出增值稅“只降不增”的指導思想，在此思想的指導下，對目前存在的增值稅稅負偏高的行業(yè)，能否進行相應的調整，讓各行各業(yè)都能充分享受到改革的紅利。對于銷售生物制品而只能取得《醫(yī)療器械經(jīng)營許可證》的企業(yè)也可采取簡易計稅的方法，按3%的征收率計稅，真正降低企業(yè)稅收負擔，促進企業(yè)發(fā)展。
相關類似：
醫(yī)療器械經(jīng)營企業(yè) 生物制品 稅點
醫(yī)療器械公司銷售生物制品簡易征收
醫(yī)療器械公司診斷試劑能簡易征收嗎
體外診斷試劑經(jīng)營企業(yè)的增值稅如何交
體外診斷試劑簡易征收依據(jù)
經(jīng)營醫(yī)療器械的企業(yè)可以申請生物試劑的簡易征收嗎
醫(yī)療檢驗試劑增值稅
關于醫(yī)療器械經(jīng)營企業(yè)銷售有關增值稅
體外診斷試劑經(jīng)營企業(yè)的增值稅如何交
生物診斷試劑行業(yè)適用的稅率
醫(yī)療器械簡易征收
醫(yī)療器械公司銷售生物體外診斷試劑能否簡易征收
關于醫(yī)療器械經(jīng)營企業(yè)銷售生物制品有關增值稅問題的公告
生物試劑公司發(fā)票稅率
醫(yī)療器械經(jīng)營簡易征收
醫(yī)療器械企業(yè)經(jīng)營體外診斷試劑簡易征收
《醫(yī)療器械經(jīng)營許可證》圖片作者：張鳳，注冊會計師、稅務師，蘭州儒霖稅務師事務所所長 、甘肅儒霖會計師事務所所長
Value added tax assessment method for medical device companies selling biologics diagnostic reagents
During our daily consultation and audit of the pharmaceutical industry, we found that companies in the pharmaceutical industry that sell medical consumables-diagnostic reagents for biological products, but only hold the Medical Device Business License, can not choose the simple method of value-added tax according to the provisions of the current tax system, thereby increasing the value-added tax of such companies. Negative, increase the burden of related taxpayers.
I. the relevant provisions of the current value added tax
1. The Circular of the State Administration of Taxation of the Ministry of Finance Concerning the Application of Low VAT Tax Rate and Simple Way to Levy VAT Policy on Some Goods (Tax [2009] 9) Item 4 of Article 2 (3) stipulates: "The general taxpayer sells microorganisms, microbial metabolites, animal toxins, human or animal blood or tissues for sale." Biological products manufactured may choose to pay VAT at a simple rate of 6% (now changed to 3%).
2. Article 1 of the Announcement of the State Administration of Taxation on the Sale of Biological Products by Pharmaceutical Trading Enterprises (No. 20 of the Announcement of the State Administration of Taxation, 2012) stipulates that "Pharmaceutical Trading Enterprises which belong to the general taxpayer of value-added tax may choose simple methods to sell biological products according to the sales volume of biological products and 3% of the sales volume of biological products." The rate of collection is calculated to pay VAT. Pharmaceutical trading enterprises refer to pharmaceutical wholesale enterprises and drug retail enterprises that have obtained the Pharmaceutical Business License issued by the Pharmaceutical Supervision and Administration Department and have been permitted to engage in the business of biological products.
In summary, the general taxpayer of VAT may choose a simple method to calculate and pay VAT according to the sales volume of biological products and the 3% levy rate, but the enterprises selling biological products must obtain the Pharmaceutical Business License issued by the pharmaceutical supervision and administration department.
Two. Concept and application of biological products
Biologicals are bioactive preparations, including vaccines, vaccines, toxins, toxoids, and immune blood, made from microorganisms, parasites, animal toxins and biological tissues, prepared by biological processes or separation and purification techniques, and controlled by biological techniques and analytical techniques for intermediate products and finished products in quality. Qing, blood products, immunoglobulins, antigens, allergens, cytokines, hormones, enzymes, fermented products, monoclonal antibodies, DNA recombinant products, in vitro immunodiagnostic products.
The application of biological products is divided into three aspects: prevention, treatment and diagnosis.
1, treatment products: including various blood preparations, immune agents such as interferon;
2, prevent vaccines;
3. Diagnostic products: mostly used to detect the corresponding antigens, antibodies or immune status of the body, can be divided into the following categories: 1) in vivo test diagnostic preparations. There are three kinds of commonly used, such as: "bu" Su, "tuberculin" and "Schick Test Toxin" (Bai Hou). (II) diagnostic preparations for general infectious diseases. It includes various diagnostic bacteria, virus solution and diagnostic serum. Diagnosis of tumor preparations. For example, alpha fetoprotein serum and carcinoembryonic antigen diagnostic kit. (4) diagnostic preparations for determining immune level. The determination of five immunoglobulins in human body is used for disease diagnosis, treatment and determination of immune function. It is also an important index for clinical diagnosis of some diseases. (5) diagnostic preparations for hormones. For example, pregnant diagnostic preparations.
3. The Confusion of Value-added Tax Selection for Medical Device Companies Selling Biological Consumables-Diagnostic Reagents
At present, the enterprises engaged in the sale of medical consumables of biological products, medical consumables of biological products - diagnostic reagents, belong to the diagnostic products of biological products, all of which are sold to the hospital laboratory, but can only obtain the "License for the Operation of Medical Devices".
Because this part of biological products is classified as "in vitro diagnostic reagents", the food and drug supervision and administration department handles the "License for the Operation of Medical Devices" according to the regulations. Medical consumables of this kind of biological products belong to: 6840 clinical laboratory analysis instruments and diagnostic reagents.
According to the current VAT provisions, enterprises that have not obtained the Pharmaceutical Business License can not choose a simple method of tax calculation, thus increasing the VAT burden of such enterprises. When purchasing diagnostic reagents for biological products from production enterprises, such enterprises may choose to adopt a simple method of tax calculation for the sale of their own biological products, and tax is calculated at a 3% levy rate. Therefore, the special invoices for value-added tax obtained by such enterprises can only deduct 3% of the value-added tax input tax, while the general taxpayer of such enterprises can export the products to other countries. When selling diagnostic reagents for biological products, the VAT rate was 17% (from 1 May 2018 to 16%) and the actual tax burden was 14%, which was a heavy burden. It is difficult for the manufacturer to obtain the VAT input ticket in the actual operation of raw materials used in the production of such biological products. Therefore, it is more likely to adopt a simple method of tax calculation and tax at a 3% levy rate.
Example: A company is a sales enterprise dealing in medical devices. It has obtained the License for the Operation of Medical Devices. 90% of the sales are biologics diagnostic reagents, all of which are sold to the laboratories of major hospitals. In 2017, 10 million yuan (excluding tax amount) of diagnostic reagents for biological products will be sold, and 8 million yuan (excluding tax amount) of diagnostic reagents for biological products will be purchased from the production enterprises. All the special invoices for value-added tax will be obtained at a tax rate of 3% (the manufacturer chooses simple tax method). The company's income will be accounted for separately. Assuming that the company has not obtained any other special invoices for value-added tax, there is no other deductible input tax.
Biological products sales tax =1000*17%=170 million.
Biological products sales tax =800*3%=24 million yuan
Biological products sales tax payable =170-24=146 million yuan
Actual tax burden =146/1000=14.6%
Four, thinking about solutions
In 2016, Premier Li Keqiang put forward the guiding ideology of "only reducing but not increasing the value-added tax". Under the guidance of this idea, whether the industries with high value-added tax burden can be adjusted accordingly so that all walks of life can fully enjoy the dividends of the reform. For enterprises that sell biological products and can only obtain the "Medical Devices Business License" can also adopt a simple tax method, according to a 3% tax rate, to really reduce the tax burden of enterprises and promote enterprise development.