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Written question asked by Christopher Chope (Conservative) on Wednesday, 13 March 2024, in the House of Commons. It was due for an answer on Monday, 18 March 2024 (named day). A holding answer was provided on Monday, 18 March 2024. A substantive answer was provided by Maria Caulfield (Conservative) on Wednesday, 20 March 2024 on behalf of the Department of Health and Social Care.

Drugs: Safety

Question

To ask the Secretary of State for Health and Social Care, with reference to the Coroner’s report entitled Oli Hoque: Prevention of future deaths report, published on 13 October 2022, what steps NHS England is taking to allow the Medicines and Healthcare products Regulatory Authority to compel the timely production of clinical data when conducting investigations into harms arising from regulated medicines.

Answer

The NHS England National Patient Safety Team and the Medicines and Healthcare products Regulatory Agency (MHRA) routinely work closely on both system development, and a number of safety issues. The NHS England National Patient Safety Team have a data sharing agreement with the MHRA, and provide regular sharing of patient safety incidents reported to NHS England, that are classified as medication incidents or medical device incidents. In addition, the MHRA are able to request focussed searches of reported incidents if they are working on a specific issue.

However, the MHRA does not have the legal powers to compel healthcare professionals to provide additional information after an initial report of a suspected adverse reaction. The MHRA has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and potentially to enable faster access to information, where considered necessary for an assessment. This work remains ongoing.

Secondary information

Type
Written question
Reference
18346
Session
2023-24
Subjects
Drugs Safety Research Medicines and Healthcare products Regulatory Agency
Link
View this Written question on www.parliament.uk