Freedom of Information request on the Pharmacovigilance reports for all Companies that had major or critical findings from July 1st 2021 – 31st September 2021 (FOI 21/1130)
Published 26 May 2022
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FOI 21/1130
10th November 2021
Dear,
As requested under the Freedom of Information Act, please find enclosed all closed Pharmacovigilance reports for all Companies that had major or critical findings from July 1st 2021 – 31st September 2021.
You will see that some information has been redacted. The relevant sections of the Freedom of Information Act are marked at the side of each redaction. These are:
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Section 40 – This information contains elements of personal data, the disclosure of which would be unfair in that it would breach the first principle of the Data Protection Act which says that information must be processed fairly and lawfully.
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Section 43 – Release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests.
Furthermore, we would like to inform you that the requested GCP inspection reports are exempted under Section 30 and Section 31.
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Section 30 - “Investigations and Proceedings Conducted by Public Authorities”
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Section 31 – Law enforcement: the information you have requested is being withheld under section 31 of the FOI Act, which applies to the release of information that may prejudice the prevention or detection of crime. Section 31 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.
We have considered the balance of the public interest when applying section 43. The exemption is to safeguard the commercially sensitive information / industrial secrets of a third party / commercial enterprise (which can include a Government Department). This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case I have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity) .
If you have any further queries, please do not hesitate to contact us at <IE&SFOI@mhra.gov.uk.>
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
IE&S FOI Team
MHRA
Inspection, Enforcement and Standards