Medicines and Healthcare Products Regulatory Agency

The complainant requested information from the Medicines & Healthcare products Regulatory Agency (“MHRA”) held by staff working on the licensing of and/or pharmacovigilance for COVID-19 vaccines about suspected adverse cardiac reactions. MHRA refused the request as it considered that compliance with it would exceed the cost limit under section 12(1) FOIA.The Commissioner’s decision is that MHRA has correctly cited section 12(1) FOIA, in response to the request. He also finds that it has complied with its obligations under section 16(1) FOIA to provide adequate advice and assistance to the complainant. The Commissioner does not require the public authority to take any further steps to ensure compliance with the legislation.