Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to enhance transparency on the data used in the approval process for weight loss drugs.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care and regulates medicine, medical devices and blood components for transfusion in the UK, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.
If a drug is assessed to have a positive benefit-risk ratio, it will be approved. Following approval, the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) will be made available, which includes details such as the patient population and conditions the drug is approved for treating. The PIL containing this information in lay language and a patient-friendly format. In addition, a Public Assessment Report will be made available which contains the non-confidential parts of the MHRA's assessment report for that particular marketing authorisation.
We continue to review practices to ensure that transparency is delivered as a key priority of the agency.