Government “carefully considering” valproate redress scheme

The House of Lords has discussed the need for a redress scheme for mothers and babies harmed by sodium valproate.

Speaking in a House of Lords debate on Tuesday March 2nd, Lord O’Shaughnessy urged the Government to adopt a sodium valproate redress scheme, as recommended in the Independent Medicines and Medical Devices Safety Review, First Do No Harm published last July.

Lord O’Shaughnessy, a former health minister, noted that since the publication of First Do No Harm, there have been a further 150 babies born suffering harm from exposure to sodium valproate. 

He said: “these children belong to families whose lives have been turned upside down, and who often cannot afford the costs of caring for their damaged children. They need and deserve a redress scheme now. Why can the Government not move faster?”

A redress scheme, if implemented, would offer financial and non-financial compensation to women and babies harmed by valproate use in pregnancy. Any such scheme could take into account the impact on social care, health and education for those affected.

Representing the Department of Health, Lord Bethell of Romford promised the Government were “carefully considering” the possibility of a redress scheme, although this was “not necessarily the correct solution to the problem.”

He promised the Government would respond in full to the Cumberlege review later this year.

The Cumberlege review refers to the committee which investigated and published First Do No Harm, led by Baroness Cumberlege.

And Bethell, who oversees the work of the Medicines and Healthcare products Regulatory Agency, said that for many patients sodium valproate was an “incredibly valuable relief from epilepsy” and that the decision to use the drug was a “personal one.”

This debate comes as the Epilepsy Society launched our Safe Mum, Safe Baby campaign last month. This campaign aims to highlight issues affecting mums and babies where the mother has taken anti-epilepsy drugs, including valproate, during pregnancy. 

During the debate, Baroness Cumberlege, who chaired the initial review which led to First Do No Harm, asked Lord Bethell about the role of GPs in informing women who take valproate of the risks associated with pregnancy. And she suggested that doctors should be incentivised to do so through the Quality Outcomes Framework which monitors patient health and GP performance. 

Lord Bethell argued that the Government was focused on ensuring women had access to the best possible advice regarding sodium valproate 

He said: 

“Our focus is on a regime ensuring that those who take this important drug have the right advice to prevent them becoming pregnant. I emphasise that specialists review the treatment and ensure that an annual risk acknowledgment form is signed by the prescriber and the patient. This is an important measure ensuring that all those who take this potentially life-changing drug acknowledge and understand the implications of becoming pregnant."

However, it was noted by peers that only 41 per cent of women taking sodium valproate have signed a risk acknowledgement form, suggesting that GPs were failing to provide the advice needed to protect women.

Bethell said that the Government were working on getting “concrete reassurance” on how many women on sodium valproate had indeed singed the form. 

Several peers spoke in support of Lord O’Shaughnessy’s question.

Lord Hunt of Kings Heath, a Labour peer, noted that there was still no definitive answer on how to minimise future harm to babies born following exposure to sodium valproate. He argued that this made the need for a redress scheme “absolutely persuasive.”

Meanwhile Baroness Thornton called on the Government to ensure a redress scheme was established on a quicker timescale than previous schemes for victims of thalidomide and contaminated blood.

Other issues touched on in the debate included the establishment of support centres for women harmed by sodium valproate use and the appointment of a Patient Safety Commissioner. 

The debate can be read in full here. 

The Epilepsy Society is currently running our Safe Mum, Safe Baby campaign to fight for mothers and babies affected by anti-epilepsy drugs in pregnancy. 

Nicola Swanborough, Acting Head of External Affairs said: “Families affected by valproate have been selfless in drawing the world’s attention to the damage caused by this epilepsy medication and it is right that full consideration should be given to a redress scheme in a timely manner. 

“It is also vital that the lessons learned from the devastating experiences of these women translate into safer medication for women in the future.

“The MHRA has highlighted the increased risk during pregnancy associated with many of the most commonly prescribed medications. And for many others, there is no evidence in order to evaluate risk.

“This is not good enough. Women with epilepsy deserve better. They deserve medications that will control their seizures without putting any unborn child at risk of physical or cognitive disabilities. The first step to achieving this is extensive data collection through an extended mandatory registry. This will allow researchers to understand at a granular level, which pregnancies are most vulnerable and hopefully, will lead to safer medications.

“Just two epilepsy drugs have been highlighted as having a safer profile during pregnancy – levetiracetam and lamotrigine. But this is of no comfort to women who have tried these medications and found they do not work for them.”