Freedom of Information request on electronic copies of the risk management plan and Modules 2.5, 2.7.3 and 2.7.4 of the marketing authorisation application submitted to the MHRA for sotorasib (Lumakras), under Project Orbis ( FOI 21/1084)
Published 26 May 2022
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FOI 21/1084
4th November 2021
Dear,
Thank you for your communication, dated 24 September 2021, in which you requested the following information:
• electronic copies (PDF, MS Word or other electronic format) of the risk management plan and Modules 2.5, 2.7.3 and 2.7.4 of the marketing authorisation application submitted to the MHRA for sotorasib (Lumakras), under Project Orbis. Can you also please provide the approved paediatric investigation plan agreed with the MHRA for Lumakras. Lastly, can you please provide the MHRA assessment reports for the MAA.
Please find attached a copy of the risk management plan for Lumykras (PLGB 13832/0051).
Information has been redacted in this document as it is exempt under Section 40 (Personal Information) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 40 would be an infringement of personal data and providing information subject to Section 43 would be an infringement of commercially sensitive data.
Section 43 is a conditional exemption, 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. We do not believe that there is an overriding public interest in disclosing this information in this instance.
Please find attached copies of Modules 2.5, 2.7.3 and 2.7.4 of the marketing authorisation application for Lumykras (PLGB 13832/0051).
Confidential information has been redacted in these documents, according to Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Section 41 is an absolute exemption and no consideration of the public interest is required. Section 43 is a conditional exemption, 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. We do not believe that there is an overriding public interest in disclosing this information in this instance.
We intend to publish a Public Assessment Report (PAR) providing details of the MHRA assessment, and this is anticipated to be available in the near future at the following link: https://products.mhra.gov.uk/
The Public Assessment report will be based on the assessment reports generated during the procedure, with commercially confidential information removed.
Section 22 of the Freedom of Information (FOI) Act provides an exemption from releasing information if it is already planned for publication. That is the situation here and therefore we are refusing your request for copies of the MHRA assessment reports. Section 22 is a qualified exemption and a consideration of the public interest is therefore necessary. We have considered the public interest and are of the view that there is no reason to provide details of the assessment, before it is ready to be published shortly within the PAR.
With regard to the approved Paediatric Investigation Plan, please note that, prior to 01 January 2021, a European Medicine’s Agency (EMA) decision of a full product specific waiver was adopted. Please find a link to the information available in the public domain below:
https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002690-pip01-19
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.
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
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Cheshire
SK9 5AF
Yours sincerely,
The FOI Licensing Team