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 recent assessment his Department has made of the reasons for the difference in availability of Omaveloxolone (Skyclarys) as a treatment for Friedrich's ataxia in (a) Scotland and (b) England and Wales; and if he will make it his policy to require the National Institute for Health and Care Excellence to set out the reasons for which new drugs that (i) have been approved by the Medicines and Healthcare products Regulatory Agency and (ii) are available in Scotland are not available in England and Wales.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has made no assessment of the reasons for the difference in the availability of omaveloxolone (Skyclarys) as a treatment for Friedrich's ataxia in Scotland, England, and Wales.
Decisions on the availability of medicines are taken by the respective health authorities in each nation of the United Kingdom. The National Institute for Health and Care Excellence (NICE) is responsible for making recommendations on the use of new medicines in England, while Scotland has its own processes through the Scottish Medicines Consortium (SMC).
NICE publishes the reasons for its decisions on its website, and the Department has no plans to require NICE to set out the reasons for differences between its recommendations and the SMC’s. NICE was unable to make a recommendation on the use of omaveloxolone for treating Friedreich's ataxia in people aged 16 years old and over because the manufacturing company, Biogen, withdrew its evidence submission. NICE will review this decision if Biogen decides to make a new submission.
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, whether he has received evidence on the potential clinical use of psilocybin under controlled conditions to treat serious psychiatric illness; whether his Department has made an assessment of the potential merits of its use; and what procedures his Department has to (a) initiate and (b) undertake such an assessment.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.
Clinical trials are underway in the UK to investigate psilocybin's use for various mental health conditions, with the open trials being in phases 1, 2, and 3, including depression, anxiety, post-traumatic stress disorder, and addiction. The MHRA is aware and is supporting the trials in this area to determine benefit versus risk. The MHRA is ready to review any data submitted to ensure an assessment of the quality, safety, and efficacy is completed rapidly upon submission.
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, how many and what proportion of PSA tests have (a) accurately diagnosed, and (b) given false (i) negative and (ii) positive diagnoses for prostate cancer in the most recent year for which figures are available.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Disease Registration Service (NDRS) in NHS England collects diagnosis and treatment data on cancer patients in England. NDRS does not hold information on the specific results of the prostate specific antigen test in the format requested.
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 his policy is on (a) routine PSA testing for males in specific age categories and (b) the reimbursement of GP practices by the NHS for providing PSA tests; and whether he has made an assessment of the potential impact of existing funding arrangements for PSA tests on the willingness of GP practices to provide routine testing.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
There is no age limit on prostate specific antigen (PSA) tests.
Advice for general practitioners (GPs) called the Prostate Cancer Risk Management Programme provides information and guidance for GPs to counsel asymptomatic men about the potential benefits and harms of PSA testing so they can make an informed decision about whether to have the test. There is no routine testing of men using PSA. They are advised to follow National Institute for Health and Care Excellence (NICE) guidance for men who they think may have symptoms that could be prostate cancer. This includes the use of PSA as a diagnostic rather than screening test.
More information on the programme is available at the following link:
https://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overview
With regards reimbursement of GP practices by the National Health Service for providing PSA tests, local enhanced services, such as blood tests, are negotiated and agreed locally, and are commissioned by integrated care boards to fit the needs of the local population. GP practices can choose whether they would like to participate in providing these services. These services can vary in scope and funding across the country. We have not assessed the potential impact of this funding arrangement for PSA tests on GP willingness to provide testing.
Where a man is symptomatic of prostate cancer, NICE guidance is clear about using the PSA test in these men. The guidance is available at the following link:
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, if he will take steps to (a) increase awareness of, (b) improve screening for and (c) develop research into lobular breast cancer; and what recent discussions his Department has had with NHS England on the (i) prevalence and (ii) detectability of this type of breast cancer.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Improving the early diagnosis of cancer, including lobular breast cancer, is a priority for NHS England. The National Health Service will improve cancer survival rates and hit all NHS cancer waiting time targets, so that no patient waits longer than they should.
To increase awareness of lobular breast cancer, NHS England and other NHS organisations, nationally and locally, publish information on the signs and symptoms of breast cancer. Further information can be found on the NHS.UK website, which is available at the following link:
The NHS Breast Screening Programme offers all women in England between the ages of 50 and 71 years old the opportunity to be screened every three years for breast cancer, to help detect abnormalities and intervene early to reduce the number of lives lost to breast cancer. However, lobular breast cancer is difficult to detect using imaging scans, such as mammogram.
The Department invests £1.5 billion each year on research through its research delivery arm, the National Institute for Health and Care Research (NIHR). NIHR research expenditure for all cancers was £133 million in 2023/24 reflecting its high priority.
The Department has invested £29 million into the Institute of Cancer Research and the Royal Marsden NIHR Biological Research Centre in 2022, supporting their efforts to strengthen research into cancer, including lobular breast cancer. Wider investments into breast cancer research include a £1.3 million project to determine whether an abbreviated form of breast magnetic resonance imaging can detect breast cancers missed by screening through mammography, including lobular breast cancer.
The Department continues to work closely with NHS England on the development of the National Cancer Plan to achieve the overall goal of fewer lives lost to cancer, including to lobular breast cancer. The plan will be published later this year.
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, if he will designate a Minister in his Department to (a) have responsibility for the field of cell and gene therapies and (b) chair his Department's Advanced Therapies Medicinal Products Coordination Group.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health, Baroness Merron, is the Minister with responsibility for life sciences and innovation, and cell and gene therapies are included in this remit.
In September 2024, the Department stood up an advanced therapies co-ordination group which aims to create a joined-up ecosystem that will support the development, regulation, and delivery of advanced therapy medicinal products in the United Kingdom. This group is chaired at the Senior Civil Service Grade 1 level. We note the recent report from the Cell and Gene Collective, titled Tomorrow’s Science, Today’s NHS, including the ask for a Minister to chair the group, and we will consider the report’s recommendations in due course.
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, if he will take steps to facilitate the circulation of material to General Practitioners advising how to (a) recognise and (b) treat with (i) antibiotics and (ii) anti-inflammatory medications the conditions of (A) Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) and (B) Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS).
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) is the independent, expert body that develops evidence-based guidelines for the National Health Service on best practice. While the NICE currently has no plans to issue guidance on paediatric acute-onset neuropsychiatric syndrome (PANS) and paediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS), should the evidence base develop further, we would look to the NICE to update clinical policy.
In the meantime, integrated care systems are responsible for planning care for their populations’ conditions, and clinicians will want to take account of any new research and developments in guidance, such as those being overseen by the PANS PANDAS Steering Group, to ensure that they can continue to provide high quality care to their patients.
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 (a) mechanisms exist and (b) steps he is taking to ensure that integrated care boards are accountable for their commissioning of children’s palliative care.
Answered by Stephen Kinnock - Minister of State (Department of Health and Social Care)
Integrated care boards (ICBs) are responsible for the commissioning of palliative and end of life care services, including for children and young people, to meet the needs of their local populations. To support ICBs in this duty, NHS England has published statutory guidance and service specifications.
NHS England has a legal duty to annually assess the performance of each ICB in respect of each financial year, and to publish a summary of its findings. This assessment must include how well the ICB has discharged its functions.
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, how many legal cases brought against the NHS by mesh-damaged women have been settled (a) in and (b) out of court in each of the past ten years.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS Resolution (NHSR) manages clinical negligence and other claims against the National Health Service in England, and while the information is not available in the format requested, they have provided the data below. This information only covers England and not the rest of the United Kingdom, and NHSR has interpreted ‘in court’ as being where the court proceedings have been served, rather than where a case has gone to trial.
Claims notified and open are not guaranteed to be settled in the same year and can take many years to be concluded. Claims notified in any given year will often relate to incidents that have occurred many years prior. Claims closed and settled in one year will often relate to claims notified in different years. Many of the claims notified will have been repudiated and settled without damages paid.
It is also possible that the same claim may appear more than once in a dataset, across different year groups, for example, where the case has been closed as unsuccessful, challenged, reopened, and closed again at conclusion.
The following table shows the number of clinical claims and incidents received between the financial years 2014/15 and 2023/24, where the claim has been identified as a vaginal mesh claim:
Year of notification | Number of claims |
2014/15 | 5 |
2015/16 | 12 |
2016/17 | 15 |
2017/18 | 54 |
2018/19 | 70 |
2019/20 | 209 |
2020/21 | 396 |
2021/22 | 226 |
2022/23 | 166 |
2023/24 | 99 |
Total | 1,252 |
Source: NHSR
In addition, the following table shows the number of clinical claims settled between the financial years 2015/16 and 2023/24 with a damages payment, where the claim has been identified as a vaginal mesh claim, broken down by litigation status:
Year of settlement and litigation status | Number of claims |
2015/16 | # |
Litigation | # |
No Litigation | # |
2016/17 | # |
Litigation | # |
No Litigation | # |
2017/18 | 16 |
Litigation | 8 |
No Litigation | 8 |
2018/19 | # |
Litigation | 8 |
No Litigation | # |
2019/20 | # |
Litigation | 11 |
No Litigation | # |
2020/21 | 32 |
Litigation | 22 |
No Litigation | 10 |
2021/22 | 61 |
Litigation | 19 |
No Litigation | 42 |
2022/23 | 116 |
Litigation | 27 |
No Litigation | 89 |
2023/24 | 101 |
Litigation | 22 |
No Litigation | 79 |
Total | 356 |
Source: NHSR
Finally, the following table shows the number of clinical claims settled between the financial years 2015/16 and 2023/24 with no damages paid, where the claim has been identified as a vaginal mesh claim, broken down by litigation status:
Year of settlement and litigation status | Number of claims |
2015/16 | # |
Litigation | # |
No Litigation | 8 |
2016/17 | # |
Litigation | # |
No Litigation | 6 |
2017/18 | # |
Litigation | # |
No Litigation | 7 |
2018/19 | 43 |
Litigation | 5 |
No Litigation | 38 |
2019/20 | # |
Litigation | # |
No Litigation | 43 |
2020/21 | 90 |
Litigation | 6 |
No Litigation | 84 |
2021/22 | 167 |
Litigation | 64 |
No Litigation | 103 |
2022/23 | 179 |
Litigation | 28 |
No Litigation | 151 |
2023/24 | 120 |
Litigation | 10 |
No Litigation | 110 |
Total | 678 |
Source: NHSR
Notes: NHSR has supressed low figures as NHSR believe that disclosure of information to a member of the public would contravene one or more of the data protection principles. In some instances, for low numbers of claims, namely fewer than 5, in each category, the likelihood exists that individuals who are the subject of this information may be identified. As this information is sensitive personal data, NHSR believes it has a greater responsibility to protect those individuals’ identities, as disclosure could potentially cause damage and/or distress to those involved. Due to small numbers in the tables, NHSR has used a ‘#’ symbol in the relevant field.
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, if he will publish current waiting lists totals at each of the mesh removal centres set up following the publication of the Cumberlege report; and whether mesh-damaged women are given an option to attend mesh removal centres other than ones led by surgeons who implanted their mesh originally.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
Tackling waiting lists is a key part of our Health Mission and we are taking steps to return to the 18-week standard. The Elective Reform Plan sets out how the National Health Service will reform elective care services to meet the 18-week referral to treatment standard by March 2029.
There are nine specialist mesh centres across England, ensuring that women in every region with complications of mesh inserted for urinary incontinence and vaginal prolapse get the right support. Each mesh centre is led by a multi-disciplinary team to ensure patients get access to the specialist care and treatment that they need, including pain management and psychological support. NHS England publishes data on referral to treatment waiting times, which is available at the following link:
https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/
Data is published at the level of specialties, for example gynaecology, and is not routinely published at sub-speciality level. The most recent waiting time data held by NHS England from 2024 indicated that the average waiting time across the nine centres was 28 weeks.
The surgery to remove mesh implanted for stress urinary incontinence and vaginal prolapse is a relatively new surgical discipline. Expertise is, therefore, concentrated in a limited number of specialist centres led by a core multi-disciplinary team, including consultant specialists in urogynaecology, urology, and pain management. Patients, when requesting treatment for mesh complications, can exercise patient choice and be referred to another centre, ensuring that they can be seen by another surgeon where appropriate.