FOI release

Freedom of Information request on clinical trials in Phenylketonurea (FOI 21/683)

Published 29 December 2021

© Crown copyright 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-clinical-trials-in-phenylketonurea-foi-21683

19th July 2021

FOI 21/683

Dear

Thank you for your information request, dated 18 June 2021 where you asked for the “below information from ongoing/completed clinical trials in Phenylketonurea (PKU). All documents should be appropriately redacted to remove any personal or data protection material:

  1. Study PKU-001 (EudraCT No: 2004-002071-16): Electronic copies of the CTA submission package (e.g. study protocol, investigator brochure) and clinical study report

  2. Study PKU-003 (EudraCT No: 2004-004512-23): Electronic copies of the CTA submission package and clinical study report

  3. Study PKU-004 (EudraCT No: 2004-004513-41): Electronic copies of the CTA submission package and clinical study report

  4. Study PKU-006 (EudraCT No: 2005-003777-24): Electronic copies of the CTA submission package and clinical study report

  5. Study PKU-008 (EudraCT No: 2006-000839-10): Electronic copies of the CTA submission package and clinical study report

  6. Study BMN162-502 (EudraCT No: 2009-015844-41): Electronic copies of the CTA submission package and clinical study report

  7. Study BMN162-503 (EudraCT No: 2009-015768-33): Electronic copies of the CTA submission package and clinical study report

  8. Study 307-201 (EudraCT No: 2019-001878-28): Electronic copies of the CTA submission package and clinical study report”

I am pleased to provide you with some of the information requested, attached to this email.

This document is provided with any personal information redacted under Section 40 of the Freedom of Information (FOI) Act, as well as any information specific to the structure or molecular formula and manufacturing process or considered commercially sensitive, under Section 41 and 43 of the FOI Act.

Other information is exempt from release under Section 21 of the FOI Act as information on the trials is available in the public domain. This also includes results related information where the trials have completed (as outlined above, results for Study PKU-001 are attached to this response). The information can be found in the following sites: https://clinicaltrials.gov and https://www.clinicaltrialsregister.eu

The remaining documentation requested has not been provided as the information was provided to MHRA in confidence, with the expectation that it will not be released, and is therefore exempt from disclosure under Section 41 of the Freedom of Information Act. Disclosure would also likely prejudice commercial interests and, therefore, exemption under Section 43 also applies. Section 41 is an absolute exemption and no consideration of the balance of public interest is required. 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 overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with an insight into the product development and design of these studies.

The FOI Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

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: [email protected].

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 Services

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