Government seeks refund over £145m ‘defective’ Covid test kits, High Court told

By Callum Parke, Reporter30th April 2024News EnglandCoronavirus / Covid-19, Courts / Justice, Government / Politics, News England

The Government is suing two companies for more than £140 million after they allegedly supplied Covid-19 test kits which “failed at an unacceptable rate”, the High Court has heard.

The Department for Health and Social Care (DHSC) is seeking a refund for thousands of “Exsig” Covid tests produced by Primer Design Ltd and Novacyt.

On Tuesday, lawyers for the Government asked a judge to rule that the companies breached a contract signed in 2020 due to the “unduly high” level of test failures, before a trial in June.

The companies claim the tests were effective and have launched their own legal claim to recover the contract’s £70 million outstanding balance.

In court, Adam Heppinstall KC, representing the DHSC, said: “The failure rate is far in excess of anything that can be tolerated in a product.”

He continued: “Time is of the essence and the quality and robustness of the test is very important. A false negative is frankly very dangerous for public health.

“A test that does not work as often as this test did not work would slow down a laboratory to the point of uselessness, which in itself is a threat to public health.”

The court was told that the DHSC signed a contract with the companies on September 28 2020, shortly before the second lockdown was declared on October 31.

As part of the deal, the companies agreed to provide 6,300 Exsig kits per week until January 28 2021, costing the Government more than £145.9 million before VAT.

Before being distributed to the public, Covid kits were tested by the Technologies Validation Group (TVG).

In November 2020, the TVG deemed that the tests should not be used due to concerns over their ability to identify Covid, and they were never rolled out across the NHS.

In written submissions, Mr Heppinstall told the court that two medical experts agreed that “Exsig failed at an unacceptable rate due to design and/or manufacturing defects and therefore lacked robustness”.

He said that Exsig tests were analysed in seven NHS laboratories, six of which found a failure rate higher than 10% – including four reporting a failure rate of 25%.

This was “at least five to 10 times over” World Health Organisation rules, which said tests should have a one or two per cent failure rate – depending on the type of test.

Mr Heppinstall claimed the tests “lacked robustness” and were “unfit for public use”, meaning the companies had breached the contract.

The DHSC requested a refund in April 2021 and took legal action a year later.

In response, the companies launched a legal claim against the Government over three unpaid invoices worth £69.7 million and other costs.

In written submissions, their barrister, Andrew Twigger KC, said that evidence of the test failures was “seriously and obviously flawed” and that a trial should take place, labelling the Government’s claim as “thoroughly bad”.

He said testing on the Exsig kits provided some results which should have been excluded, and that a test could fail for “all kinds of reasons”.

He said: “Once these results are removed from the TVG analysis, and other errors made by TVG are corrected, there is no evidence that the sensitivity of the Exsig Kits reported by the NHS laboratories who provided information for the TVG validation exercise was less than 100%.”

He continued: “Were it not for the errors made by TVG in its assessment of the laboratory results, the Exsig kits would never have been rejected on sensitivity grounds and this claim would never have been brought in the first place.

“Faced with that difficulty, the Government is attempting to mount a rearguard action in the form of this ‘robustness’ claim, which on analysis is unsustainable.”

The hearing before Mrs Justice Jefford continues.