Freedom of Information request on the autologous dendritic cell vaccine production (FOI 22/506)
Published 31 May 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-28-february-2022/freedom-of-information-request-on-the-autologous-dendritic-cell-vaccine-production-foi-22506
FOI 22/506
2nd March 2022
Dear
Thank you for your email.
Thank you for your interest in this particular autologous dendritic cell vaccine, unfortunately, due to grounds of commercial sensitivity our current policy is to neither confirm nor deny whether an application is held, this approach is applied in conjunction with Sections 41 and 43 of the Freedom of Information Act (FOIA).
Section 41 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. Section 43 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 alerting competitors to whether a competitor is close to obtaining a marketing authorisation or not.
Please note we continue to work closely with our colleagues across the health system to help bring cutting-edge medicines to patients, and we always seek to ensure that applications we receive are evaluated in the shortest time possible, whilst maintaining our high standards of safety, quality and effectiveness.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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