FOI release

Freedom of Information request 1. All emails discussing the Innova tests exchanged between MHRA officials and DHSC ministers and Cabinet Office Ministers since December 2020 (FOI 21/820)

Published 31 May 2022

FOI 21/820

13th December 2021

Dear

Thank you for your information request dated 20 July 2021 asking us for:

1. All emails discussing the Innova tests exchanged between MHRA officials and DHSC ministers (both current and former) since December 2020
2. All emails discussing the Innova tests exchanged between MHRA officials and Cabinet Office ministers (both current and former) since December 2020
3. Internal emails exchanged between MHRA officials discussing the renewal of the special authorisation of the Innova tests, since May 2021

In relation to the second point above.  I confirm that there has been no correspondence between MHRA officials and Cabinet Office ministers (both current and former) since December 2020 regarding Innova tests.

Unfortunately, the information you have asked for in points 1 and 3 is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA).

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 Innova Medical Group Inc, a  business which continues to exist.

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. MHRA provided Department of Health and Social Care (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. In the UK, Innova Medical Group Inc is the supplier of tests used by DHSC)/NHS Test and Trace

Information on the EUA process can be found here: Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak - GOV.UK (www.gov.uk)

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected].

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.

The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000