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 nine 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.

In its full response to the review in July 2021, the Government said that it “fully accepts the overarching conclusion that the system failed to listen to patients, or to put patients at the centre of their care.” 

The Government accepted recommendations on the establishment of a new Patient Safety Commissioner role, specialist centres for the care of those with complications from mesh implants, and changes to how conflicts of interests for doctors are reported.  It did not accept the recommendation on the setting up of an independent redress agency for those harmed by mesh implants, and medicines in pregnancy.

This briefing provides an overview of the Independent Medicines and Medical Devices Review and its recommendations, and the Government’s response to this.