Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if she will make date of birth a mandatory field when reporting a suspected adverse reaction to the Yellow Card scheme run by the Medicines and Healthcare products Regulatory Agency.

For medicines and vaccines, the Medicines and Healthcare products Regulatory Agency (MHRA) aligns with internationally recognised pharmacovigilance standards including the International Council for Harmonisation E2B (R3) standard for the collection and transmission of adverse reaction data. While reporters are encouraged to provide as much relevant information as possible, including date of birth where known, a valid individual case safety report is only required to contain sufficient information to identify a patient, such as age group, sex, initials, or a patient medical record number. In general, the MHRA seeks to collect sufficient information to support effective safety monitoring, whilst maintaining a proportionate and accessible system to encourage reporting from healthcare professionals, patients and carers. Requiring information that may not always be immediately available could create an unnecessary barrier to potential reporting rates.