SV, known by Epilim and other brand names, has been prescribed in the UK since 1972. It was known from the outset to be harmful to the developing foetus if taken when pregnant. Evidence emerged over subsequent decades of SV’s effects on unborn children. By 1990, risks of spina bifida, cleft palate and lip were known. In the 2000s, effects on development were recognised including delayed walking and talking, lower IQ and poor speech and language skills. More recently, an increased incidence of autistic spectrum disorders was highlighted.

Government figures estimate an 11 per cent chance of a birth defect and 30-40 per cent chance of babies having development disorders, potentially higher depending on the SV dose taken by mothers.

The effects of Fetal Valproate Syndrome, or Fetal Anticonvulsant Syndrome, are not always obvious at birth. Delayed development might not be recognised until usual milestones are not achieved. Diagnosis may not be straightforward and there is no cure.

Spina bifida, cleft lip/palate or heart defects can be addressed by operations, but complex issues, such as autism and learning difficulties, can be hidden.

In 2020, Baroness Cumberlege’s report, First Do No Harm, called for financial redress for those with life-changing injuries, with patient-focused research bringing out important themes from medical misadventures. Recommendations in many areas included SV, and advocated a redress scheme to meet the cost of providing additional care and support to those who had experienced avoidable harm .

This was reiterated in August when media campaigns on SV highlighted tragic situations. Recent interim compensation payments by the UK Government to those affected by historic administration of infected blood products is a model that should be adopted.

What next?

● Establish a Government Inquiry to look at historic practices, and effects, of SV in pregnant women. There is a UK-wide precedent in the Infected Blood Inquiry;

● Set up a fund for ex-gratia payments, such as already made through the Infected Blood Inquiry;

● Provide more funding for healthcare specialists, to advise and provide equipment and support to affected children and families.

● Inform women about current scientific knowledge, making them fully aware of potential risks and benefits, with appropriate medical advice. There may not be an alternative drug to adequately control some patients’ seizures, so pre-conception counselling is vital.

● Ensure future safety. A Patient Safety Commissioner (PSC), recommended in First Do No Harm, has been under discussion and consultation. The Scottish Government has published a Bill to establish a PSC - not restricted to medical devices, as originally proposed, but covering all healthcare providers operating in Scotland. I hope the SV issue will be looked at.

● Address financial compensation. In Scotland, families affected currently need to bring a civil claim for medical negligence, based on established tests. It is likely claimants will have to prove a case against doctors or a health board by either showing a lack of informed consent by the patient to the prescription of the drug, or alternatively, that the prescription was a breach of duty, and the doctor acted as no ordinarily competent doctor would have done if using ordinary skill and care. It is unlikely any claim against a manufacturer of the drug would be successful.

In England, NHS Resolution is responsible for advising the NHS on civil claims. It has a clear, step-by-step guide on how to proceed and patients can progress a claim without professional assistance, although the requirement to provide certain evidence to prove the case is daunting for anyone not legally or medically qualified.

There is nothing equivalent in Scotland. Patients will need to consult a solicitor before they even begin to know where to address such a claim. This requirement for specialist advice and funding is a major barrier to obtaining justice and compensation.

In conclusion, the historic provision of Sodium Valproate is an area requiring thorough investigation, and redress for those affected. Just as important is addressing current provision and patient awareness. Providing Scotland with a PSC is a laudable aim. With sufficient determination, accountability and effective powers, it is hoped benefits will be secured in this area, and across the board for healthcare in Scotland.

Ann Logan is a Partner, Balfour+Manson

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Government Inquiry should be established into historic Sodium Valproate practices - Ann Logan