Freedom of Information request on Paediatric Investigation Plan for molnupiravir (FOI 21/1205)
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-6-december-2021/freedom-of-information-request-on-paediatric-investigation-plan-for-molnupiravir-foi-211205
FOI 21/1205
8th December 2021
Dear
Thank you for your email dated 11th November, where you requested an electronic copy of the approved Paediatric Investigation Plan agreed with the MHRA for molnupiravir (Lagevrio).
Unfortunately, the release of the full information regarding an ongoing paediatric investigation plan for a medicinal product is exempt from release under sections 41 (information provided in confidence) and 43 (commercial interests) of the Freedom of Information (FOI) Act 2000.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing competitors with the details of the development plan for a rival product for use in the paediatric population. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity
However, please be aware that decisions and the summary of the agreed studies for MHRA approved Paediatric Investigation Plans (PIPs) are published on our website at the following link https://cms.mhra.gov.uk/. There is an easy to search section on the PIP landing page and the documentation relating molnupiravir (Lagevrio) has now been published and can be accessed from here.
We hope you find this information useful.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected].
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 online: https://ico.org.uk/make-a-complaint/foi-and-eir-complaints/foi-and-eir-complaints/official-information-concerns-report/
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division