Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Ministry of Justice:
To ask the Secretary of State for Justice, what assessment he has made of the potential impact of the withdrawal of legal aid in cases involving sodium valproate on the long-term care needs on people who have brought such cases forward.
Answered by Sarah Sackman - Minister of State (Ministry of Justice)
Legal aid was granted in respect of a multi-party action product liability dispute under the Consumer Protection Act 1987 against Sanofi, the manufacturers of Epilim, a sodium valproate containing medication. The availability of legal aid in connection with this matter was subject to a means and merits test.
Legal aid funding was subsequently withdrawn on the basis that the case no longer met the merits test because the prospects of success in the case were assessed as being poor. This determination was subject to an appeal before the Special Cases Review Panel, a panel consisting of independent lawyers, in October 2010. When determining whether legal aid should be withdrawn all relevant factors were taken into account. The assessment of long-term care needs following a withdrawal of legal aid is not a process that is part of the legal aid scheme and there is no statutory provision which requires or envisions this happening.
At the material time the Legal Services Commission (LSC), an executive non-departmental public body of the Ministry of Justice, was responsible for the operational administration of the legal aid scheme. Decisions about funding in individual cases were made independently in accordance with the statutory framework in place. At the relevant time this would have included the Access to Justice Act 1999 and the Funding Code Criteria and Guidance. Exceptional Case Funding (ECF) would not have been available for this matter as the case was in scope of legal aid under the Access to Justice Act 1999.
In 2013, the LSC was replaced by the Legal Aid Agency (LAA), an Executive Agency of the Ministry of Justice, created by the Legal Aid Sentencing and Punishment of Offenders Act 2012 (LASPO). Under LASPO, the scope of civil legal services funded under legal aid was significantly reduced. ECF as provided for under s.10 LASPO allows legal aid to be granted in respect of cases which fall outside the scope of civil legal aid services where it can be shown that, without legal aid, there would be a breach or a risk of a breach of the individual’s human rights or assimilated enforceable EU rights. However, as with in-scope legal aid eligibility is subject to a financial eligibility test and a legal merits test, including where appropriate, the prospect of success test.
The nature and availability of ECF is published on GOV.UK and the LAA publishes detailed guidance on how to apply for ECF Legal aid: apply for exceptional case funding - GOV.UK. All solicitors have an obligation in accordance with professional body rules to advise clients about funding options available including legal aid whether provided as in-scope funding or ECF.
The independence of decision making in individual cases under LASPO was preserved by the creation of the statutory role of the Director of Legal Aid Casework. The Lord Chancellor may not issue directions or guidance in relation to an individual case. It is this separation that enables the LAA to make decisions without influence from the Ministry of Justice or from Ministers. This is an important part of the legal aid system and ensuring access to justice.
All applications for legal aid, whether in-scope or ECF, are considered on a case-by-case basis against the statutory framework and any applicable general guidance issued by the Lord Chancellor. Legal aid will be granted in all cases where the appropriate eligibility criteria are met.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Ministry of Justice:
To ask the Secretary of State for Justice, what information his Department holds on the withdrawal of legal aid certificates in litigation cases relating to harm caused by sodium valproate; and whether people involved in such cases were aware of the availability of Exceptional Case Funding.
Answered by Sarah Sackman - Minister of State (Ministry of Justice)
Legal aid was granted in respect of a multi-party action product liability dispute under the Consumer Protection Act 1987 against Sanofi, the manufacturers of Epilim, a sodium valproate containing medication. The availability of legal aid in connection with this matter was subject to a means and merits test.
Legal aid funding was subsequently withdrawn on the basis that the case no longer met the merits test because the prospects of success in the case were assessed as being poor. This determination was subject to an appeal before the Special Cases Review Panel, a panel consisting of independent lawyers, in October 2010. When determining whether legal aid should be withdrawn all relevant factors were taken into account. The assessment of long-term care needs following a withdrawal of legal aid is not a process that is part of the legal aid scheme and there is no statutory provision which requires or envisions this happening.
At the material time the Legal Services Commission (LSC), an executive non-departmental public body of the Ministry of Justice, was responsible for the operational administration of the legal aid scheme. Decisions about funding in individual cases were made independently in accordance with the statutory framework in place. At the relevant time this would have included the Access to Justice Act 1999 and the Funding Code Criteria and Guidance. Exceptional Case Funding (ECF) would not have been available for this matter as the case was in scope of legal aid under the Access to Justice Act 1999.
In 2013, the LSC was replaced by the Legal Aid Agency (LAA), an Executive Agency of the Ministry of Justice, created by the Legal Aid Sentencing and Punishment of Offenders Act 2012 (LASPO). Under LASPO, the scope of civil legal services funded under legal aid was significantly reduced. ECF as provided for under s.10 LASPO allows legal aid to be granted in respect of cases which fall outside the scope of civil legal aid services where it can be shown that, without legal aid, there would be a breach or a risk of a breach of the individual’s human rights or assimilated enforceable EU rights. However, as with in-scope legal aid eligibility is subject to a financial eligibility test and a legal merits test, including where appropriate, the prospect of success test.
The nature and availability of ECF is published on GOV.UK and the LAA publishes detailed guidance on how to apply for ECF Legal aid: apply for exceptional case funding - GOV.UK. All solicitors have an obligation in accordance with professional body rules to advise clients about funding options available including legal aid whether provided as in-scope funding or ECF.
The independence of decision making in individual cases under LASPO was preserved by the creation of the statutory role of the Director of Legal Aid Casework. The Lord Chancellor may not issue directions or guidance in relation to an individual case. It is this separation that enables the LAA to make decisions without influence from the Ministry of Justice or from Ministers. This is an important part of the legal aid system and ensuring access to justice.
All applications for legal aid, whether in-scope or ECF, are considered on a case-by-case basis against the statutory framework and any applicable general guidance issued by the Lord Chancellor. Legal aid will be granted in all cases where the appropriate eligibility criteria are met.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Ministry of Justice:
To ask the Secretary of State for Justice, whether his Department has made an assessment of the potential merits of making Exceptional Case Funding available to women and families on their legal cases relating to harm caused by sodium valproate.
Answered by Sarah Sackman - Minister of State (Ministry of Justice)
Legal aid was granted in respect of a multi-party action product liability dispute under the Consumer Protection Act 1987 against Sanofi, the manufacturers of Epilim, a sodium valproate containing medication. The availability of legal aid in connection with this matter was subject to a means and merits test.
Legal aid funding was subsequently withdrawn on the basis that the case no longer met the merits test because the prospects of success in the case were assessed as being poor. This determination was subject to an appeal before the Special Cases Review Panel, a panel consisting of independent lawyers, in October 2010. When determining whether legal aid should be withdrawn all relevant factors were taken into account. The assessment of long-term care needs following a withdrawal of legal aid is not a process that is part of the legal aid scheme and there is no statutory provision which requires or envisions this happening.
At the material time the Legal Services Commission (LSC), an executive non-departmental public body of the Ministry of Justice, was responsible for the operational administration of the legal aid scheme. Decisions about funding in individual cases were made independently in accordance with the statutory framework in place. At the relevant time this would have included the Access to Justice Act 1999 and the Funding Code Criteria and Guidance. Exceptional Case Funding (ECF) would not have been available for this matter as the case was in scope of legal aid under the Access to Justice Act 1999.
In 2013, the LSC was replaced by the Legal Aid Agency (LAA), an Executive Agency of the Ministry of Justice, created by the Legal Aid Sentencing and Punishment of Offenders Act 2012 (LASPO). Under LASPO, the scope of civil legal services funded under legal aid was significantly reduced. ECF as provided for under s.10 LASPO allows legal aid to be granted in respect of cases which fall outside the scope of civil legal aid services where it can be shown that, without legal aid, there would be a breach or a risk of a breach of the individual’s human rights or assimilated enforceable EU rights. However, as with in-scope legal aid eligibility is subject to a financial eligibility test and a legal merits test, including where appropriate, the prospect of success test.
The nature and availability of ECF is published on GOV.UK and the LAA publishes detailed guidance on how to apply for ECF Legal aid: apply for exceptional case funding - GOV.UK. All solicitors have an obligation in accordance with professional body rules to advise clients about funding options available including legal aid whether provided as in-scope funding or ECF.
The independence of decision making in individual cases under LASPO was preserved by the creation of the statutory role of the Director of Legal Aid Casework. The Lord Chancellor may not issue directions or guidance in relation to an individual case. It is this separation that enables the LAA to make decisions without influence from the Ministry of Justice or from Ministers. This is an important part of the legal aid system and ensuring access to justice.
All applications for legal aid, whether in-scope or ECF, are considered on a case-by-case basis against the statutory framework and any applicable general guidance issued by the Lord Chancellor. Legal aid will be granted in all cases where the appropriate eligibility criteria are met.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Government plans to mandate structured medication reviews for patients receiving long-term sodium valproate, particularly as part of antiepileptic polytherapy.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
There are no current plans to mandate Structured Medication Reviews (SMRs) specifically for patients receiving long-term sodium valproate. NHS England has, however, provided substantial funding to expand the number of clinical pharmacists working in primary care networks, with a key part of their role being to undertake SMRs for groups of patients who are most likely to benefit. Whilst treatment with sodium valproate does not, in itself, guarantee an SMR, an SMR might be triggered if a patient meets certain criteria, for example, if they are considered to have complex and problematic polypharmacy or if they are in a care home.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking with the Minister for the Cabinet Office to help tackle the harm caused by sodium valproate to (a) women with epilepsy and (b) their families.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
Action has been taken to minimise the risk associated with valproate to women with epilepsy, and their families. This includes the valproate Pregnancy Prevention Programme, which ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. Further measures introduced in 2024 mean valproate must not be started in new patients, either male or female, younger than 55 years old, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
The Government is also carefully considering the Patient Safety Commissioner’s recommendations made in The Hughes Report, which includes proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps are being taken to ensure cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
There are established systems within the National Health Service to ensure that cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate. In practice, this involves establishing arrangements for assessing, reviewing, and monitoring the ongoing need for treatments, and, given that sodium valproate is almost invariably initiated in secondary care, clear shared-care arrangements between secondary and primary care clinicians, supported by the involvement of pharmacists, to minimise the risks associated with cumulative drug toxicity and polypharmacy.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what learning has been implemented following the coroner’s finding that harm from sodium valproate exposure contributed to the death of Jake Aldcroft.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
Action has been taken to minimise the risk of foetal harm associated with valproate, and to ensure that healthcare professionals are also able to support any babies and families that are affected. The valproate Pregnancy Prevention Programme ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. It is supported by educational materials for healthcare professionals and patients.
The programme was updated in January 2024 to reflect updated Medicines and Healthcare Products Regulatory Agency advice that valproate must not be started in new patients, either male or female, younger than 55 years old, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether NHS England plans to commission specialist multidisciplinary services for people affected by sodium valproate exposure, including care coordination, to help reduce emergency admissions and diagnostic times.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the adequacy of the diagnostic time taken and levels of misdiagnosis among individuals harmed by sodium valproate, and its impact on long-term outcomes.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of whether NHS care pathways are adequate for individuals harmed by sodium valproate that require lifelong, multidisciplinary care.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.