Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate he has made of the number of the number of pregnant women prescribed sodium valproate in the latest period for which figures are available.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The latest available data from 2019/20 shows that 81 women on the Medicines and Pregnancy Anti-Epileptics Registry were prescribed valproate during their pregnancy. This represents a decrease of almost 15% from 2018/19, where 95 women were prescribed sodium valproate during their pregnancy.
Women should not be prescribed valproate without a Pregnancy Prevention Programme (PPP) in place. The Registry allows us to monitor implementation of and adherence to the PPP and understand changes in the use of valproate and the impact on women and their children.
Asked by: Feryal Clark (Labour - Enfield North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he plans to respond to his Department's consultation on original pack dispensing and supply of medicines containing sodium valproate which closed in December 2021.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The responses to the consultation are currently being considered and reviewed. We intend to publish the consultation response in due course.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the dedicated webpage for those negatively affected by sodium valproate will be published on NHS Resolution's website.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
NHS Resolution continues to work with the Department to establish a single gateway for patients affected by mesh and sodium valproate seeking to bring a claim. NHS Resolution aims for the gateway to be available by the end of April 2022.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether those negatively affected by sodium valproate will be eligible for legal aid when pursuing a claim through NHS Resolution.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Legal Aid, Sentencing and Punishment of Offenders Act 2012 redefined the scope of civil legal aid and a number of matters, including most medical negligence cases, are no longer covered by public funding. Legal aid may be available under the exceptional case funding scheme, where failure to provide it would breach or risk breaching human rights under European Court of Human Rights or European Union law. Legal aid for clinical negligence remains for cases where a child has serious neurological injuries and as a result is severely disabled, subject to meeting certain conditions.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate he has made of the potential total value of claims of clinical negligence linked to sodium valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
NHS Resolution handles clinical negligence claims on behalf of National Health Service organisations and independent sector providers of NHS care in England. As at 31 March 2022, NHS Resolution had received 127 claims relating to sodium valproate, of which seven are currently open. The total amount paid in damages and costs for the 120 closed cases relating to sodium valproate is £14.6 million. The value of the remaining seven open cases has yet to be determined.
Asked by: Julian Lewis (Conservative - New Forest East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department plans to take in response to the letter to the Parliamentary Under-Secretary of State from Marie Lyon, Association for Children Damaged By HPT, Kath Sansom, Sling The Mesh, Emma Murphy and Janet Williams, In-Fact, on behalf of people damaged by vaginal mesh, sodium valproate and Primodos on the implementation of the recommendations of the Independent Medicines and Medical Devices Safety Review 2020 led by Baroness Cumberlege.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Department’s central correspondence team have no record of receiving this letter. We would be happy to respond formally if the letter could be re-sent to the Department.
The Government’s response to the Independent Medicines and Medical Devices Safety Review accepted the majority of the nine strategic recommendations and 50 actions for improvement. The recommendations and actions for improvement included vaginal mesh and sodium valproate. We aim to publish an update on implementation of the accepted recommendations in the summer.
Asked by: Stephen Metcalfe (Conservative - South Basildon and East Thurrock)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what financial provision he has made to support the health needs of those affected by Sodium Valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Those affected by sodium valproate may be in receipt of Continuing Healthcare where individuals with long-term complex health needs qualify for free social care arranged and funded solely by the National Health Service. Personal Health Budgets are also available to support health and wellbeing needs, which is planned and agreed between the individual or their representative and the local clinical commissioning group.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the Government is taking to support the adults and children harmed by sodium valproate in pregnancy and who suffer from health issues as a consequence of that medication.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Multidisciplinary teams within local child development centres manage services for children with neurodevelopmental disorders to ensure assessment, support and treatment, including specialist treatment, are integrated across health, maternity, education and social care systems.
The National Health Service has commissioned the Paediatric Neurosciences Clinical Reference Group to support the development of pathways of care service specification to improve patient support and co-ordination. A multi-disciplinary expert clinical group with experience in responding to and managing teratogen exposure has been established. The Group will report its recommendations to NHS England and NHS Improvement in March 2022.
Asked by: Ben Lake (Plaid Cymru - Ceredigion)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what information is provided by the Department and NHS England to midwives on the use of sodium valproate in pregnancy in order to help them prepare an expectant mother of the teratogenic effects.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
NHS England and NHS Improvement have commissioned the Paediatric Neurosciences Clinical Reference Group to develop care pathways and a service specification to improve for patient support and co-ordination for children affected by teratogen exposure. A multi-disciplinary group including patient representatives and expert clinicians with experience in responding to and managing teratogen exposure has been established. The group will report its recommendations to NHS England and NHS Improvement in March 2022.
The Royal College of Obstetricians and Gynaecology’s guidance recommends that all women with epilepsy of childbearing age are counselled on the risk of sodium valproate. In the first instance, this will take place with the woman’s neurologist and general practitioner. The Royal College recommends that such counselling is provided by a clinician competent in the management of epilepsy, usually a neurologist and or an obstetrician with a special interest in epilepsy. Midwives may take a supporting role, unless they specifically work in this context and have obtained additional training.
Asked by: Ben Lake (Plaid Cymru - Ceredigion)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what practical steps he is taking to ensure that the experiences and interests of children with fetal valproate syndrome and their families are represented as an integral part of patient involvement at every level of the NHS in England.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
NHS England and NHS Improvement have commissioned the Paediatric Neurosciences Clinical Reference Group to develop care pathways and a service specification to improve for patient support and co-ordination for children affected by teratogen exposure. A multi-disciplinary group including patient representatives and expert clinicians with experience in responding to and managing teratogen exposure has been established. The group will report its recommendations to NHS England and NHS Improvement in March 2022.
The Royal College of Obstetricians and Gynaecology’s guidance recommends that all women with epilepsy of childbearing age are counselled on the risk of sodium valproate. In the first instance, this will take place with the woman’s neurologist and general practitioner. The Royal College recommends that such counselling is provided by a clinician competent in the management of epilepsy, usually a neurologist and or an obstetrician with a special interest in epilepsy. Midwives may take a supporting role, unless they specifically work in this context and have obtained additional training.