Viet A's test kits
In its prior official dispatches to manufacturers, importers, and suppliers of biological products for testing, the Ministry of Health strictly prohibited price gouging, speculation, and hoarding. Moreover, biological product manufacturers, importers, and suppliers must take responsibility for the published price and completeness of information related to goods as prescribed.
Explaining about the license to circulate biological testing products of Viet A Company, the Ministry of Health said, as per the Minister of Science and Technology’s Decision No. 489/QD-BKHCN dated March 2, 2020, the Council for Biologics Evaluation of a national independent project on prevention of acute respiratory infections caused by a new strain of coronavirus "Research and manufacture a kit RT-PCR and real-time RT-PCR biological products to detect a new strain of coronavirus 2019” requested the Ministry of Health to license the use of two sets of real-time PCR biological products to diagnose SARS-CoV-2 on March 3, 2020.
This national science and technology task carried out between the Military Medical Academy and Viet A Company was approved by the Ministry of Science and Technology. Based on the council’s evaluation result, the reports of the Central Institute of Hygiene and Epidemiology, the Bureau Veritas’ verification that the product has met ISO 13485:2016 standard, the Ministry of Health has granted temporary use permits for the two sets of biological products mentioned above in six months from March 4, 2020.
Chairwoman of the Vietnam Fatherland Front Committee of Ho Chi Minh City To Thi Bich Chau
The Ministry of Health said that approval of test kit licensing has ensured to meet the demand for testing at a time when it is very difficult to access the supply of biological products in the world. Moreover, the Ministry added that Viet A Company’s LightPoweriVA SARS-CoV-2 RT-PCR Kit was licensed for circulation within five years on December 4, 2020.
Regarding Viet A Company’s test kits that have not been recognized by the World Health Organization (WHO) but have been still licensed for use, the Ministry of Health said for emergency use, any company in the globe should submit documents to WHO for consideration.
However, each country and organization has different criteria and requirements for documents and products on approval for the circulation of biological products. Therefore, the Ministry’s licensing of Viet A Company’s products and other manufacturers does not depend on WHO’s list.
Regarding the price of biological products for testing and the bidding, the Ministry of Health said that according to the provisions of the Law on Price, medical equipment and biological products for testing are not on the item list of price management. Prices of medical equipment and biological products for testing are determined through bidding, and the prices of products vary from time to time and by procurement quantity and supply capacity.
The Ministry of Health has urged and required suppliers in the market to publicize prices of medical equipment and the winning bid results. Currently, more than 1,600 businesses have publicly announced their selling prices of over 60,000 items of medical equipment and 93,253 winning bids on the portal.
At the same time, Viet A Company listed the price of test kits at VND470,000 for each product on the portal while Sao Thai Duong Company listed the PCR test price at VND300,000 a product and the LAMP test at VND385,000 product and Ampharco USA Company’s products cost VND179,800 each. Fifteen imported PCR products have been licensed for registration and listed at prices ranging from VND280,000 to VND600,000 a product.
The Ministry of Health emphasized that localities can procure and bid for medical equipment to meet the needs of epidemic prevention and control in the location according to the provisions of the law on bidding.
Regarding issues related to corruption in the prevention of epidemics, the Ministry of Health has issued a lot of guidance in procurement, bidding and use of services over the past time. Therefore, the price hike of the Covid-19 test kit of Viet A Company is very serious. Individuals and the company leader must receive proper punishment.
In related news, Ho Chi Minh City voters asked to clarify responsibility for information disclosure that WHO approved the test kit of Viet A Company.
They were speaking at a meeting with deputy To Thi Bich Chau, who is chairwoman of the Vietnam Fatherland Front Committee in HCMC, and other deputies of the 10th HCMC People's Council in Binh Chanh District after the 4th session of the HCMC People's Council.
At the meeting, voters expressed anger as substandard test kits will have serious consequences in the prevention of the epidemic, affecting people's health. Therefore, they recommended that authorities ought to clarify the responsibilities of individuals who announced that WHO approved the test kit of Viet A Company.
On behalf of deputies, Chairwoman of the Vietnam Fatherland Front Committee of Ho Chi Minh City To Thi Bich Chau revealed that the Ministry of Public Security is being carried out an investigation of the case.