In February 2018, the Secretary of State for Health and Social Care announced the setting up of a review into how the health system in the UK responds to reports from patients about harmful side effects from medicines and medical devices. This followed lobbying on behalf of those affected by the anti-epileptic drug, Sodium Valproate, the hormone pregnancy test Primodos and surgical mesh. The review is called the Independent Medicines and Medical Devices Safety Review and is chaired by Baroness Cumberlege.
Terms of Reference
Draft Terms of Reference for the review were issued and “sent to stakeholders, including patients groups, regulators and manufacturers, who have been given until 31 July 2018 to respond with any major observations.” That deadline has now passed and we understand that Baroness Cumberlege and her team have now begun the task of considering all evidence and submissions.
As the Terms of Reference make clear, “the review may make recommendations on any forms of redress, including recommendations as to whether there is a moral and social responsibility to consider a system of compensation where it concludes that there has been avoidable harm. It will not make findings upon whether, in an individual’s case, such harm has been suffered.”
It is not yet known when the findings of the review will be published.
No fault compensation scheme
Leading Sodium Valproate Solicitor, David Gazzard, who has attended Parliament and was invited to contribute to the evidence submission said:
“Whilst I’m pleased that the review team have now begun the process of considering the evidence, I expect there to be a fairly lengthy wait until we know whether a no fault compensation scheme is recommended for the thousands of children who have been injured by the harmful effects of Sodium Valproate during pregnancy. I believe that is the best outcome we can expect from the review.
“In the House of Commons, Norman Lamb MP’s description of this being a national scandal was very apt. I fully expect that what we know so far is barely the tip of the iceberg. In addition to those suffering from epilepsy, it’s likely that there are a great many more migraine and bi-polar sufferers who have also taken this drug without the benefit of proper advice and counselling and as a result their children are now living with the consequences of Fetal Valproate Syndrome.”