Information Commissioner's Office

Medicines and Healthcare Products Regulatory Agency

3 November 2016, Health (Other)

The complainant has requested a range of information taken from voluntary reports of adverse incidents involving medical devices. The MHRA agreed to disclose some information but considered that model, manufacturer, catalogue, serial and batch numbers, and date of incidences of adverse incidents was exempt on the basis of section 41, 43 and 44 of the FOIA. In addition to this, the MHRA also considered that section 43 applied to the request for reference numbers. The Commissioner’s decision is that the MHRA has correctly withheld the information request at parts 2, 3, 4, 5, 6 and 10 of the request on the basis of section 44. However, she does not consider that the MHRA has sufficiently demonstrated that section 43 is engaged in relation to the information requested at part 16 of the request. The Commissioner requires the public authority to disclose the information requested at part 16 of the request – MHRA reference numbers for all voluntary reports of adverse incidents received since 1 April 2003.

FOI 43: Upheld FOI 44: Not upheld