Chinese-Made Covid Tests Exempted From New UK Mandatory Health Standards
Move to stamp out ‘poor quality’ tests won’t cover products that have already cost taxpayer billions
Ministers have tightened up the law to raise standards for Covid tests sold privately in England – but have exempted Chinese-made tests which have cost the taxpayer billions, HuffPost UK can reveal.
New regulations from the department of health and social care (DHSC) aim to stamp out “poor quality tests” that could give the public a false sense of security and allow people to spread the virus unwittingly.
But the higher performance standards, quietly introduced this week, include a loophole that explicitly excludes lateral flow tests previously bought by the government such as those bought from Innova Medical Group at a cost of more than £3bn.
British manufacturers privately welcome the new regime as they believe their home-grown tests are cheaper and more reliable than the Innova tests.
But many in the UK bio industry question why ministers are exempting the Chinese-made devices from the same high standards.
The rules, which will kick in from September 1, have also prompted fresh suspicions that the government is moving away from giving the public and businesses free rapid tests and will instead expect them to pay for the devices commercially.
The new secondary legislation – The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 – gives Sajid Javid unprecedented power over which Covid tests can be sold on the open market in England.
Firms will have to pay the government £14,000 for any application and any tests not deemed up to the grade will be removed from sale by law.
Retailers, distributors and manufacturers of tests that attempt to sell unvalidated tests would face sanction.
Currently, PCR or lateral flow tests can go on commercial sale in England as long as they carry a CE mark, which means they meet EU and UK requirements, but each manufacturer designs their own data collection and analysis methods to validate them.
Under the new proposals, the government will require that “all COVID-19 tests placed on the UK market undergo a mandatory validation process”, with the same standards applied equally to allow consumers to make a fair comparison.
A new DHSC document states: “It would undermine current public health goals if people used poor quality tests that give them a false sense of security.
“In the case of a false negative, this could see an infected individual unknowingly spread the virus. Conversely false positives could require business to close and people to isolate unnecessarily.”
But an explanatory memorandum to the new legislation states that “tests supplied by government will be exempt” from the new validation process.
The memo adds that contracts agreed by the government to supply NHS hospitals “can continue to be honoured by the manufacturer even if the test has failed validation”.
This has prompted anger among UK bioscience insiders, who believe that the Innova tests would compare badly with British-made rivals and who complain that ministers have done everything to favour the Chinese-manufactured products since last year.