The Independent Medicines and Medical Devices Safety Review

The Independent Medicines and Medical Devices Safety review was announced by the former Secretary of State for Health and Social Care, Jeremy Hunt, in February 2018 to look at three issues of concern:

• the use of primodos (the hormone pregnancy test);
• use of the anti-epileptic drug sodium valproate in pregnancy; and
• the use of vaginal mesh.

Following the consideration of written and oral evidence from patients and their families, campaigners, healthcare professionals and regulators over a two-year period, the review published the report of its findings and recommendations, First do no harm, in July 2020.

There were eight main recommendations. These included the establishment of an independent Patient Safety Commissioner, the introduction of redress schemes for those affected by these products, and changes to the way the medicines regulator, the Medicines and Healthcare products Regulatory Agency, works with patients.

The Government have responded to the review’s report.  It has accepted a number of the recommendations and has taken measures in the Medicines and Medical Devices Act 2021 to make provision for the patient safety commissioner.  Other recommendations were not accepted by the Government, and some remain under consideration.

A debate on a Motion relating to the implementation of the recommendations of the Independent Medicines and Medical Devices Safety Review has been tabled by the Backbench Business Committee on 8 July 2021.  The debate will be led by Emma Hardy and Alec Shelbrooke.

This briefing provides an overview of the Independent Medicines and Medical Devices Review and its recommendations, and the Government’s response to this.  Further press articles and parliamentary material are also included.