Freedom of Information request on a copy of all responses received to the questions set out in Chapter 7 (Clinical Investigation / Performance Studies) of the "Consultation on the future regulation of medical devices in the United Kingdom" (FOI 21/1263)
Published 31 May 2022
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FOI 21/1263
23rd December 2021
Dear,
Thank you for your information request, dated 25 November 2021, where you asked for a copy of all responses received to the questions set out in Chapter 7 (Clinical Investigation / Performance Studies) of the “Consultation on the future regulation of medical devices in the United Kingdom” up to the closing time of the consultation (midnight on 25 November 2021), including the identity of the party submitting each response.
Unfortunately, the information relating to the first element of your request, a copy of all responses received to the questions set out in Chapter 7, is exempt from release under section:
Section 35 – Formulation of Government policy: the information you have requested is being withheld under section 35 of the FOI Act. Section 35 protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Section 35 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.
In favour of disclosure, we consider that there is a general public benefit from releasing the information on the grounds of transparency in the making of government policy. However, we consider that the public interest will be better served by not releasing the information as the premature disclosure of the information requested could be taken out of context or misinterpreted and be detrimental to the policy making process. Disclosure of the information provided during the consultation would inhibit free and frank discussions with essential external stakeholders in the future, leading to damage to the quality of advice and lead to poorer decision making in the future.
The proposals included in the public consultation do not constitute agreed policies. The MHRA has held the public consultation to obtain evidence to be used to develop policies, prior to these being agreed by the Secretary of State. There are no plans to publish the responses received to Chapter 7 of the public consultation, though a Government report of the consultation responses will be published in early 2022 and will include a section on Chapter 7.
In relation to the second part of your request, that information be provided on the identity of the party submitting each response, I can confirm that we do not hold the information that you have requested as it was not requested as part of the consultation submission process.
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
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000