Rebecca has been campaigning for the women and their families who have been affected after taking sodium valproate during pregnancy.
Sodium Valproate was first licensed in the UK to treat epilepsy and bipolar disorder in 1972, despite the fact it was known to be harmful to a developing foetus in animals. Several women and children raised their concerned that exposure to sodium valproate during pregnancy had caused serious harms and that there had been no or an inadequate warning of the associated risks. It has now been definitively linked to autism and learning disabilities in children when taken during pregnancy.
Rebecca has been campaigning alongside the women and their families affected by this so that they receive the financial compensation they rightly deserve. Rebecca was formerly a member of the All Party Parliamentary Group for Valproate before her role as a Government Whip and has met with members and representatives from INFACT, the national valproate campaign on several occasions.
CUMBERLEGE REPORT:
In 2018, the Secretary of State for Health and Social Care Jeremy Hunt MP subsequently announced a review led by Baroness Julia Cumberlege. The Cumberlege Review or the Independent Medicines and Medical Devices Safety Review laid bare the consequences of a healthcare system that does not listen to the experiences of women and made for sober reading.
Following this, the Conservative Government accepted the vast majority of her recommendations and oversaw the introduction of a new statutory duty of candour requiring NHS trusts to inform patients when their safety has been compromised, new legal protections for whistleblowers and the launch of the new NHS Patient Safety Strategy.
HEALTH AND CARE ACT 2022:
Through the Health and Care Act 2022, which Rebecca supported, the Health Services Safety Investigations Body has been established, a new independent body which will look at claims of serious safety issues. We also now have the first-ever Women’s Health Strategy for England to address the historical imbalance for women’s healthcare and this will have a huge impact on outcomes and patient safety.
MHRA RECOMMENDATIONS:
The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new recommendation that sodium valproate is not offered to new female patients under the age of 55 if they have never taken it before and if it is, then it should only be prescribed after 2 specialists have independently looked at the patient’s case and determined that no other medicine is available for them. For those women who are already taking it, 2 specialists will need to independently consider and document that no other medicine is effective or tolerated and that the patient should continue to receive it.
The NHS and MHRA has also established the Pregnancy Prevention Programme, ensuring that women are fully aware of the risks of taking sodium valproate during pregnancy. They have also now introduced the Medicines and Pregnancy Registry which monitors the effectiveness of this programme by holding data on all women and girls of childbearing age who are taking this and making sure they are accessing the necessary support through the services available.
COMPENSATION:
Conservative Ministers worked with NHS Resolution to launch a new specific Claim Gateway for sodium valproate and mesh implants, allowing people to bring forward medical negligence claims, including sources of independent legal advice. You can check if you are personally eligible for this here: https://resolution.nhs.uk/sodium-valproate/
As part of the Cumberlege Review recommendations, the Conservative Government appointed Dr Henrietta Hughes OBE as the first Patient Safety Commissioner for England to focus on holding the NHS and Government to account, to champion patients and improve safety of medicines and medical devices. She was asked by Conservative Ministers upon taking this role to undertake a review of those affected after taking sodium valproate to understand the scale of its impact and provide options for redress.
The Commissioner has now delivered her report and Rebecca had spoken to the previous Health Minister about this. The Conservative Government had written to the Patient Safety Commissioner in May 2024 to provide an initial response to the report, highlighting the need for primary legislation to make redress payments, and that more work was required to consider the financial redress options proposed.
We now have a new Labour Government and so Rebecca has written to the new Patient Safety Minister, Baroness Merron and asked her what plans Health Ministers and the Department of Health and Social Care have more widely to bring forward this legislation. Rebecca will continue to raise this until the Labour Government have responded in full to the Commissioner’s report, so that the women and families affected by sodium valproate gain the compensation they rightly deserve.