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Sodium Valproate patient groups will press for action on Cumberlege Review recommendations

Groups representing families affected by the use in pregnancy of the epilepsy drug, Sodium Valproate, are determined to press on to see the recommendations of the Cumberlege Review fulfilled as soon as possible.

23 July 2020

The Independent Medicines and Medical Devices Safety Review, by which Baroness Julia Cumberlege published her report, First Do No Harm, will cease to exist from Friday, 31 July.
 
Then, it will be down to patient groups to apply pressure to see Baroness Cumberlege’s recommendations accepted and actioned by the Secretary of State for Health and Social Care, Matt Hancock.
 
Sodium Valproate patient groups, FACSaware, Valproate Victims, OACS and Connate, anticipate that a scheduled debate in the House of Lords during the Second Reading of the Medicines and Medical Devices Bill will present an opportunity to highlight the importance of the Cumberlege recommendations.
 
The debate was due to be held on Monday, 27 July, but has been postponed until September, time which the groups will use to brief peers and to talk to their MPs. 
 
The First Do No Harm report followed Baroness Cumberlege’s investigation into the consequences of the use of Sodium Valproate in pregnancy, as well as Primodos and vaginal mesh.
 
Recommendations which Sodium Valproate groups are keen to see fulfilled as soon as possible are:
 
  • The appointment of a Patient Safety Commissioner
  • An independent Redress Agency for those harmed by medicines and medical devices
  • A cost-of-care scheme to meet the costs of additional needs caused by avoidable harm
  • Networks of specialist centres to provide comprehensive treatment and act as a ‘one-stop shop’ to signpost and refer patients to other services
 
Represented by Leigh Day solicitors, the Sodium Valproate patient groups have already written to Matt Hancock to ask that he gives these matters his urgent attention.
 
In their letter sent Friday, 17 July, the groups stressed there is a lot of work to be done to set up a Redress Scheme that implements Baroness Cumberlege’s recommendations faithfully, “makes proper provision for the needs” and “facilitates dignity, autonomy and control for affected families and sufferers”.

They wrote:

“The patient groups are in the process of bringing together an expert working group of specialists in the field of the product liability, regulatory law and social services and care, to put forward proposals for a redress scheme based on our collective experience and research in this area. We suggest that DHSC appoint a group to work with our group to arrive at a workable mechanism for supporting FVSD sufferers, as soon as possible.”

Leigh Day Partner Boz Michalowska-Howells represents the patient groups. She said:

“Experience with other compensation funds established after medical product failures, such as Thalidomide, suggests that these matters will need urgent attention.

“The Independent Medicines and Medical Devices Safety Review will cease to exist from Friday, 31 July. Then it will be down to the patient groups to convince the Secretary of State for Health and Social Care to carry out the recommendations of the Cumberlege Review.

“The patient groups are looking to Matt Hancock to work with us to set up a working party to make sure these vital recommendations are fulfilled.

“Baroness Cumberlege made it clear in her report that she had listened to the suffering of families whose children are afflicted by Foetal Valproate Syndrome.

“Now it is time for others to turn her immense sympathy into action that will help to make amends and to make life easier in some measure.”

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