Freedom of Information request on the Risk Management Plan for Glycopyrronium Bromide 2mg Tablets (FOI 21-271)
Published 28 May 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-5-april-2021/freedom-of-information-request-on-the-risk-management-plan-for-glycopyrronium-bromide-2mg-tablets-foi-21-271
9th April 2021 FOI 21/271 Dear
Re: FOI 21/271 - a request for the clinical overview and Risk Management Plan for Glycopyrronium Bromide 2mg Tablets (PL 44710/0018)
Regarding your email of 09 March 2021, where you requested the clinical overview and Risk Management Plan (RMP) for Glycopyrronium Bromide 2mg Tablets (PL 44710/0018), please find attached the RMP requested. Redactions have been made to the RMP under Section 40 (personal information), Section 41 (information provided in confidence) and Section 43 (commercial interests). Section 40 is an absolute exemption and no consideration of the public interest is required. Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider the disclosure of this information 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 releasing information that can be used by competitors to inform their own product development or can be used to overcome regulatory hurdles to get their product onto the market quicker. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.
Regarding the clinical overview, unfortunately we will not be able to answer within the 20 working days specified in the Freedom of Information (FOI) Act. The Marketing Authorisation Holder for this product licence has raised objections to the release of the information. These objections would be covered by Section 43 of the FOI Act (commercial interests), which is subject to a test of public interest. In accordance with Section 17(2) and 2(2)(b), the 20 working days can be extended by a reasonable period to consider the public interest in view of the objections raised. The act does not define what a reasonable period is, however, MHRA typically applies 20 working days to consider the test of public interest.
Based on the above, the deadline for fully responding to the above request will now be close of business Monday 10 May 2020.
Best regards
The FOI Licensing Team