Medicines and Healthcare Products Regulatory Agency

The complainant has requested information about COVID-19 vaccines and their safety. The Medicines and Healthcare products Regulatory Agency (MHRA) directed the complainant to where relevant information is published. It withheld some information under section 40(2) and 41(1) of FOIA, which concern personal data and information provided in confidence respectively. MHRA has subsequently relied on section 12(1) to refuse to comply with the request for information not covered by section 40(2) and 41(1). The Commissioner’s decision is as follows: Relevant information that MHRA received from other regulators is exempt from disclosure under section 41(1) of FOIA and the individual Yellow Cards are exempt under both section 41(1) and section 40(2). MHRA is not obliged to comply with the request for any other relevant information as the cost of doing so would exceed the appropriate limit under section 12(1) of FOIA. MHRA has not complied with its duty under section 16(1) to offer the complainant advice and assistance. MHRA breached section 17(5) of FOIA as it has not issued the complainant with a section 12 refusal notice within the required time of 20 working days. The Commissioner requires MHRA to take the following step to ensure compliance with the legislation: Comply with the duty under section 16(1) of FOIA to assist the complainant in submitting a refined request, so far as it is reasonable to do so.