Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will make it his Department's policy to introduce a care compensation plan similar to plans already introduced in other EU states for people harmed by valproate prescribed during pregnancy since 1973.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps the Government is taking to reduce the number of babies harmed by valproate prescribed during pregnancy.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will meet the Chair of the All-Party Parliamentary Group on anti-epileptic drugs in pregnancy to discuss the effect of people harmed by sodium valproate prescribed during pregnancy.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will meet people who have been harmed by sodium valproate during pregnancy; and what steps he has to provide compensation to such people.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what support the Government plans to provide to children and young adults affected by valproate after their birth (a) now and (b) over the next 10 years.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
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, what measures the Government is taking to support children with birth defects as a result of valproate taken during pregnancy.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
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, if he will meet with INFACT to discuss a care plan compensation package for people harmed by Valproate in pregnancy since 1973.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
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, what steps his Department is taking to reduce the number of babies harmed by Valproate in pregnancy.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
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, if he will commission research into the care plan for people harmed by Valproate during pregnancy in France in order to identify potential benefits that such a plan could bring to the UK.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether the Expert Working Group on Hormonal Pregnancy Tests will review (1) the terms of reference of (a) the Committee on the Safety of Medicines, and (b) the Metabolic Research Unit, when determining what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy, (2) the need to assemble and assess reports of adverse reactions to drugs trials, and (3) how ministers should be advised of the outcomes of those trials.
Answered by Lord O'Shaughnessy
One of the terms of reference of the Expert Working Group on Hormonal Pregnancy Tests is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. The regulatory, legal and social landscape has changed significantly since hormonal pregnancy tests were on the market; many of these changes have been driven by previous experience. The Group will consider the processes and tools that were available to the United Kingdom regulator when hormonal pregnancy tests were on the market and make recommendations for any changes necessary to further improve the capability of current regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. This will include all aspects of medicines regulation, from the assessment of safety pre-authorisation to communication of an identified risk.
There has been continued engagement with the Association for Children Damaged by Hormonal Pregnancy Tests throughout the Expert Working Group review process. I am meeting the All Party Parliamentary Group on Hormone Pregnancy Tests and representatives of the Association in the near future.