Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the (a) level and (b) adequacy of data collected by (i) mandatory and (ii) voluntary reporting of adverse clinical events by health professionals before the introduction of the Yellow Card reporting system in England compared to that now collected via the Yellow Card system.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed other international mandatory and non-mandatory reporting systems for healthcare professionals and found limited evidence that making reporting mandatory increases the ability to detect safety signals. Very few international mandatory reporting systems have a better reporting rate or a more successful system for detecting safety signals than the United Kingdom.

In both medicines and devices legislation there are requirements for manufacturers to report, but there is no legal obligation for healthcare organisations. However, there are professional body standards and guidelines that make reporting a gold standard for healthcare professionals. The MHRA continues to work with partners across the healthcare system to promote and encourage use of the Yellow Card scheme to help detect safety issues.

The MHRA has reviewed global approaches to mandatory reporting in other regulatory systems and continues to consider the approach in the UK as we work to improve reporting capability and functionality through systems.