Freedom of Information request on the access to the clinical study report documents for COSENTYX (FOI 21/1143)
Published 27 April 2022
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18th October 2021
FOI 21/1143
Dear
In recent weeks we have received 13 FOI requests from your company from both business and personal email addresses. These FOI requests have all been substantially similar and therefore have been amalgamated.
I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
In order to process your request, we would need to: retrieve and redact as appropriate the many files which have been requested. We consider that this would take longer than 24 working hours to complete.
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
We are currently working on FOI 21/1104 for your company, and have previously requested that no further requests are sent until this FOI request has been responded to. As we have continued to receive these requests we would like to reiterate this request. We are not able to provide the amounts of information which your company has been requesting and we consider the use of personal email address to submit these requests an improper use of the Freedom of Information system. Should we continue to receive these requests we will be denying all requests including this under Section 14, vexatious requests.
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 would 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.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency