Freedom of Information request on regulatory approval of Debendox (FOI 22/528)
Published 14 June 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-11-april-2022/freedom-of-information-request-on-regulatory-approval-of-debendox-foi-22528
FOI 22/528
11th April 2022
Dear
Thank you for your email of 8th March where you have asked “Please could you provide copies of ALL toxicity/teratogenicity studies that were performed on the two active ingredients (in combination) of Dicyclomine and Doxylamine (without Pyridoxine) for the morning sickness drug Debendox.
Could you also provide information of who was responsible for conducting all of Debendox safety assessments prior to marketing in Uk. Also, who was responsible for approving Debendox in UK, and who the manufacturer was in UK”
The names of MHRA staff who conducted the safety assessments and approved the product in the UK are exempt under Section 40 (personal information) and Section 38 (Health and safety). Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information. Section 38 (Health and safety): the information is withheld under section 38 of the FOI Act because we consider that its disclosure would, or would be likely to endanger the physical or mental health, or the safety, of any individual. Section 38 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.
The sites of manufacture are exempt under S41 (Information provided in confidence) and S43 (Commercial interests).
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.
Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest arguments that outweigh the commercial harm in providing information that can aid a competitor in their product development and help them overcome regulatory hurdles to get their product onto the marketing quicker.
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 will 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.
Yours sincerely
MHRA Customer Experience Centre