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Dagbladet has gained access to documents showing that a Norwegian provider of laboratory services and equipment contacted Hospital Procurement in October, shortly after Health Minister Bent Høie (H) confirmed that Norway had obtained five million rapid tests from foreign manufacturers Abbott and Roche. .
The price was NOK 280 million.
In the documents, the supplier Sykehusinnkjøp, who was responsible for the procurement on behalf of Helse Sør-Øst, requests an account of the agreements concluded and asks why a public tender round was not held, as required by law. Public tender rounds will ensure that tax money is used in the best possible way and that acquisitions contribute to a competitive business community.
In response, Sykehusinnkjøp confirmed that the agreements had been concluded with the manufacturers and wrote that “The antigen tests included in these agreements are validated by FHI and considered the best in the current market in terms of sensitivity and specificity.»
In addition, the procurement service for the specialized health service wrote that “This mission was defined as very important for Norway to complete its infection tracking task, and that this was urgent. That is why they were admitted direct agreements», shows the documents that Dagbladet has accessed.
NOT VALIDATED: Hospital Procurement claimed to a Norwegian medical equipment supplier that the rapid tests that Norway had purchased were validated by NIPH. At the same time, the purchasing service confirmed that the rapid tests were purchased without public tender. Photo: Montasje / Dagbladet
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FHI: Misunderstanding
The Norwegian provider then contacted the National Institute of Public Health (NIPH) and asked for information on the validation of the rapid tests, which Hospital Purchasing claimed to have performed.
The documents Dagbladet has obtained access to to demonstrate that FHI’s response was concise and clear:
“There is probably some misunderstanding here. FHI has not validated any rapid antigen tests, but it will be done in connection with the purchase that has been made.”
On Monday 2 November, the rapid tests that Norway has bought were launched for testing in a pilot project at Aker’s test station in Oslo. Senior Director and Health Assistant Espen Nakstad will report on the project results and plans for the use of the tests at a press conference at 1pm on Thursday.
– Regulations do not allow exceptions
Dagbladet has asked Sykehusinnkjøp and Helse Sør-Øst on the basis to write that the rapid tests had been validated by FHI, and “were considered to be the best” on the market at the time.
Executive Vice President Atle Brynestad at Health South-East responds to the following in an email:
“The development of new drugs and tests has been extremely rapid during this pandemic and it has not been possible to predict what will develop and when and, therefore, not to monitor which acquisitions it would be possible or desirable to make. Nor has it been possible to predict which strategy will be adequate to maintain the best possible control of the pandemic. There is no doubt that the unwanted spread of the virus will pose a danger to life and health.
The urgent situation with the increase in the development of infections in the fall of 2020, the strategy and the requirements of the authorities to carry out extensive tests and access products that were marketed at short notice, made it not possible to meet all deadlines of Chapter 20 of the Public Procurement Regulations (FOA). it had to be done quickly to secure deliveries to Norway.
The acquisition was made in accordance with FOA §13-3, letter e, and a contract with two suppliers was entered into after negotiations.
Product information from suppliers was reviewed. In addition, there was information from the Norwegian Health Directorate. “
They do not answer the question of the basis to state that the rapid tests were validated by FHI.
Dagbladet has also asked Sykehusinnkjøp and Helse Sør Øst if they consider it appropriate for Norwegian suppliers to make direct agreements with foreign companies as in this case, but they have not been able to get an answer to this question either.
Sacrificed
Dagbladet has previously written that the rapid tests Norway has bought have been euthanized in a French study. The study was released by the Statens Serum Institut of Denmark on November 2, and states that the rapid tests have a lower precision than the manufacturers themselves claim, between 50 and 60 percent. The manufacturers themselves claim that the accuracy is between 85 and 95 percent.
The minimum requirement of the World Health Organization (WHO) for rapid antigen tests is that they must be proven “Significantly more cases than undetected (sensitivity (precision) ≥80 percent compared to PCR) and have high specificity (≥97-100 percent)”writes FHI in their guidelines.
In a letter sent to Norwegian municipalities on Thursday morning, ahead of the announced press conference on rapid tests at 1 p.m., it appears that the Norwegian Health Directorate has revealed that rapid tests are accurate to 74.4 percent. This means that 1 in 4 received a negative test result in the pilot project in Oslo, even though they had a corona infection.
Therefore, rapid tests do not meet the WHO minimum requirements for such tests. However, more than a million of them are now sent to the country’s municipalities, distributed according to the population of the municipalities, the letter says.
‘The rapid antigen test can be used when quick results are needed. This is especially important in the case of the elimination of infections in connection with the outbreaks. In some cases, the PCR test is recommended in addition to the rapid test. “writes the Norwegian Health Directorate in the letter.
TRIED: Oslo Health Advisor Robert Steen (left) and Deputy Health Director Espen Rostrup Nakstad were present when rapid tests for coronavirus began at the Aker test station in November. Photograph: Håkon Mosvold Larsen / NTB
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Defend the evidence
Høie has previously defended the tests and said the tests are now being used in Norway, in a Norwegian context, to see how the tests work here.
– The results are currently more optimistic, Høie told the government press conference on the status of the crown on November 13.
– What we see in some of the international studies is that they are based on people doing the tests themselves. Then it may be that the result is like the study in France. But if you put it in a system where there are healthcare professionals and guidelines for when they are used, we can achieve other results. That is what we are testing in Norway, Høie said.
Dagbladet has attempted to obtain a comment from FHI on the case, but did not receive a response Thursday afternoon.
