Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Independent Medicines and Medical Devices Review, published July 2020, what steps he is taking to fulfil recommendation six of that review, and whether he plans to make adverse event logging mandatory.

In response to the Review, the Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a substantial programme of work to improve how it listens to patients and the public, to evolve United Kingdom medicines and medical devices regulation, develop a more responsive system for reporting safety incidents and strengthen the evidence to support timely and robust decisions that protect patient safety.

The Agency’s Delivery Plan published on 4 July sets out how the MHRA will deliver better patient and public involvement and a more responsive safety surveillance and risk management system. This includes the transformation of the Yellow Card reporting system where work has already begun. The MHRA is reviewing the issue of making reporting of adverse events mandatory for healthcare professionals and will be discussing this with other partners in the healthcare system with a view to making firm proposals in quarter 4 of 2021/22.