3rd August 2021
FOI 21/756 and Enquiry dated 30/07/2021
Dear
Thank you for your information request, dated 2nd July. You requested:
• to be given “the data and rationale in this decision”
We have determined the decision to which you are referring is related to the extension of the Department of Health and Social Care/NHS Test and Trace exceptional use authorisation which was reported on gov.uk: Following a satisfactory review, MHRA extends authorisation of NHS Test and Trace lateral flow devices – GOV.UK (www.gov.uk)
We have also received a further information request dated 30th July in which you requested:
• I wish to know the basis of the extended authorisation of the Innova LFT antigen test.
• What led to the satisfactory review?
• What is the regulator doing?
• I am requesting the information which led to this outcome.
The Department of Health and Social Care (DHSC) / NHS Test and Trace have published data on 7th July 2021 on lateral flow test performance:
https://www.gov.uk/government/publications/lateral-flow-device-performance-data .
We recommend that you contact the legal manufacturer (DHSC) directly who may be able to offer you more information.
Unfortunately, the information requested with regards to be given the data presented to MHRA is exempt from release under Section 44:
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
• constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
• relates to the affairs of DHSC, a business which continues to exist.
On that basis we are satisfied that section 44 of FOI Act apply, and the information is exempt from release.
In December 2020, MHRA provided DHSC with an Exceptional Use Authorisation. Please see the list of medical devices given exceptional use authorisations here: https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations
This permitted DHSC/NHS Test and Trace to deploy a repurposed professional use test (i.e. Innova COVID-19 lateral flow test kit) as a self-test throughout the UK as a test to detect infection in asymptomatic individuals. In exceptional circumstances the MHRA can issue Exceptional Use Authorisations (EUAs) allowing medical devices to be used that have not followed the standard regulatory approval process. The EUA process has been used during the pandemic to ensure that the health system has access to critical products. Once an EUA is issued following an assessment by the MHRA, the products given approval are closely monitored by the MHRA.
The EUA extension was granted subject to a number of conditions including a requirement to re-evaluate the performance of the test. You may request a copy of the Exceptional Use Authorisation conditions from the legal manufacturer (DHSC/NHS Test and Trace). The burden of proof is on the legal manufacturer to provide sufficiently robust data as to be able to demonstrate that their test performs as intended. Should there be an application for a further extension, we will follow our usual processes which involves requirements for further data, a robust internal review and input from external experts where required. As part of our safety and surveillance activities MHRA reviews a range of data sources to triangulate information sent to us by legal manufacturers.
Information on the EUA process can be found here: Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak – GOV.UK (www.gov.uk)
Based upon the evidence we have reviewed to date we believe that there is a satisfactory likelihood that when used in combination with other measures the DHSC rapid lateral flow self-tests have the potential to moderately reduce the number of infected individuals entering events or conducting activities through the identification of some positive cases. However, this is heavily reliant on the compliance and behaviour of participants and evidence of impact is yet to be demonstrated. We will continue to press DHSC/NHS Test and Trace to generate and demonstrate this evidence and to make it publicly available.
It is the role of DHSC and NHS Test and Trace to determine how the tests are deployed in the UK and to ensure that they are fit for purpose.
In your latest enquiry, you referenced the action taken by the FDA in the USA.
In relation to the safety action taken by the US Food and Drug Administration (FDA), the MHRA carefully considered the areas of non-compliance identified. The FDA safety action focused on three areas of non-compliance with their regulations:
1. that tests were being sold without the appropriate FDA approvals;
2. that there were discrepancies around the documented performance of the tests; and
3. that Innova did not have an appropriate Quality Management System (QMS) in place.
In the UK, Innova Medical Group is the supplier of tests used by Department of Health and Social Care (DHSC)/NHS Test and Trace. DHSC/NHS Test and Trace have taken on the role of legal manufacturer of the self-tests which, as explained above, have been given an MHRA Exceptional Use Authorisation (EUA) for the purpose of detection of COVID in asymptomatic individuals as part of the national testing programme.
On becoming aware of the FDA safety notice issued on 10 June, in line with our normal processes MHRA immediately asked DHSC/NHS Test and Trace – as legal manufacturer of the test in the UK – to investigate whether the UK could be affected by any of the concerns raised by FDA. MHRA undertook a rapid assessment of the information submitted by DHSC/NHS Test and Trace in addition to our regular analysis of post-market surveillance data provided to us as part of the conditions of the EUA.
In the UK, the Innova professional use test is legally placed on the market as it carries the CE mark and is registered with MHRA by the legal manufacturer Xiamen Biotime. The repurposed self-tests supplied by DHSC/NHS Test and Trace are legally on the market as explained above they have an EUA from MHRA. The terms of the EUA require DHSC to re-evaluate the performance of the test and report regularly to MHRA. DHSC operate their own quality management system independent of that of Innova Medical Group.
Taking all of the above considerations into account, we were satisfied that there was limited applicability of the FDA’s actions in the USA to the products supplied in the UK by DHSC/NHS Test and Trace and we were satisfied by the actions proposed by NHS Test and Trace to mitigate any risks.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
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