FOI release

Freedom of Information request on clinical trial documents for RoActemra (FOI 21/974)

Published 17 January 2022

17th September 2021

FOI 21/974

Dear

Thank you for your information request, dated 23 August 2021 where you asked for the following electronic copies of the clinical trial documents:

• RoActemra (Tocilizumab) Investigator’s Brochure

• RoActemra (Tocilizumab) Study protocol, Statistical Analysis Plan, and Clinical Study

Report for the following 6 clinical studies:

Study name (EudraCT number)

1. WA17822 (2004-003741-40)

2. WA17823 (2004-003733-14)
3. WA18062 (2005-000884-25)
4. WA18063 (2004-005210-37)
5. WA22762 (2010-018375-22)
6. NA25220 (2010-019912-18)

I am pleased to provide you with some of the information requested, attached to this email. I can confirm that we do not hold the information that you have requested for four of the clinical trials listed. In addition, the MHRA does not hold Statistical Analysis Plans for clinical trials. The documents are provided with any personal information redacted as well as any information considered commercially sensitive, under Section 40, 41 and 43 of the Freedom of Information Act.

Other information is exempt from release under Section 21 of the Freedom of Information Act as information on the trials is available in the public domain. This also includes results related information where the trials have completed. The information can be found in the following sites: https://clinicaltrials.gov and/or 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 Freedom of Information 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

[email protected]