Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database.

The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes.

As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.