Follow-up on the IMMDS report and the government’s response

The Health and Social Care Committee has published a report on the Independent Medicines and Medical Devices Safety recommendations, and the government’s response to those recommendations.

The Independent Medicines and Medical Devices Safety (IMMDS) Review, “First Do No Harm”, also known as the Cumberlege report, was published in July 2020. The report examined how the healthcare system had responded to concerns raised by patients and families about three medical interventions:

• the hormone pregnancy test Primodos
• the anti-epileptic drug sodium valproate
• surgical mesh

The Review included nine general recommendations covering each one of these medical procedures, in addition to various recommendations specific for sodium valproate prescription.

The initial response by the government, published in January 2021, was generic and did not cover the recommendations specific for valproate. A second, more detailed response was given on 21 July 2021. While the government accepted some of the recommendations, other key recommendations were rejected.

The new follow-up, published on 17 January 2023 by the Health and Social Care Committee, arrives after an evidence session on the IMMDS report held on 13 December 2022. At the session, a panel of MPs was able to hear personal experiences from those affected by these procedures, while also discussing any progress made on the recommendations from the Cumberlege Review.

Emma Murphy, from In-Fact, a charity that campaigns for people diagnosed with Fetal Valproate Syndrome (FVS), shared their experience as a mother with epilepsy who was prescribed with sodium valproate while pregnant.

In their report, the Health and Social Care Committee, acknowledge that, since April 2018, 286 women have been prescribed sodium valproate in a month in which they were pregnant. The report also stressed the importance of a rigorous system that can protect both people with epilepsy who are pregnant, and babies.

In the evidence session, Janet Williams, co-founder of In-Fact, highlighted the lack of a functioning Pregnancy Prevention Programme (PPP) and the lack of information shared with patients who are pregnant or are of childbearing age.

The Health and Social Care Committee report also highlighted research suggesting that people affected by sodium valproate exposure as an unborn baby could potentially pass on effects to their own children.

It is fundamental that the government, in line with other European countries, investigates this matter as soon as possible.

The lack of trackable data collection to monitor long-term effects from sodium valproate (among Primodos and surgical mesh), as recommended by the Cumberlege Review, represents a fundamental fault in the medical system and a threat to patient safety. While a valproate registry has been established by NHS Digital, the system is not currently able to track patient outcomes.

Recommendation 2 of the Cumberlege Review was the formation of a Patient Safety Commissioner. The Review set out the idea of an independent commission to promote patient’s safety regarding medicines and medical devices.

While the government accepted this recommendation, only small steps have been taken since then. Dr Henrietta Hughes was appointed in July 2022 as Patient Safety Commissioner but she, herself, shared their concerns on the role and the lack of adequate resource designed to make it a functioning body.

Recommendation 4 from the Cumberlege Review was to establish a redress scheme for those affected by the three medical interventions. The Health and Social Care Committee’s report highlights the rejection by the government of this recommendation, despite the fact that the families of those harmed face increased care costs due to the harm they have experienced. In December 2022, the Government published an update on its initial response, directing those seeking to raise a clinical negligence claim to the NHS Resolution (NHSR) website.

Such a response is, however, inadequate, as it does not ease the process of raising claims. Emma Murphy, during the evidence session, said: “We have tried the route of clinical negligence against the NHS, and that has failed. Even to suggest that to parents is an insult, and it continues the insult to our families to keep suggesting that and to keep knocking our families back”.

Indeed, the Health and Social Care Committee, while recognising the improvement in communication and information online about how to bring claims of clinical negligence, believe that such pathway cannot be a substitute for those who are seeking redress.

As an organisation that campaigns for people with epilepsy, Epilepsy Action believes that by not providing a redress scheme, the government fails to understand the devastating consequences that valproate have had on many families and individuals. As noted by the Health and Social Care Committee, a redress scheme does not look for someone to blame, rather, it aims to bring some support (even if only economic) to victims of a system that should have protected them and their babies and failed to do so.

This follow-up has highlighted the slow speed of the government in addressing and implementing the recommendations it has accepted. Moreover, it demonstrates that much more must be done before people who have been affected by sodium valproate, among others, are treated justly.