Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 4 July (HL8829), what assessment they have made of whether the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme includes non-pharmaceutical or medical device treatments; and whether they will make arrangements so that adverse reactions to treatments that are not currently within the remit of the MHRA can be centrally recorded in order to ensure that information on the frequency, severity and duration of adverse reactions to cognitive behaviour therapy, graded exercise and other similar treatments is available.

No such assessment has been made and there are currently no plans to broaden the coverage of the Yellow Card Scheme to cover these areas.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. The MHRA provides information to doctors and patients to help ensure medicines are used safely. However, the prescribing of any particular medicine and matters of clinical care of the patient remains the responsibility of the doctor/clinician. He or she is in the best position to decide on the type of treatment, which is most appropriate for an individual patient given their clinical expertise and their knowledge of the patient’s medical condition. The MHRA does not regulate clinical practice, collect reports on or investigate allegations of medical malpractice.