Freedom of Information request (FOI 22/874)
Published 17 January 2024
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FOI 22/874
24th August 2022
Dear
Thank you for your email of 5 August 2022, where you requested “communications to or from third parties about the data and/or marketing protection period that applies to Biogen’s product Tecfidera (dimethyl fumarate) in the UK. Please provide any communications from 1 January 2022 to 31 July 2022. For the avoidance of doubt, communications from Biogen are not requested.”
MHRA refuses to confirm or deny we hold any information relevant to your request, under Section 41 (S41) and Section 43 (S43) of the Freedom of Information Act (FOIA). S41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. S43 is a conditional exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in acknowledging whether we have received such communications, which will alert companies to whether or not competitors are looking to enter the market.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Please remember to quote the reference number above in any future communications.
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 at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre