Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance his Department provides to NHS bodies regarding engagement with external academic publications that discuss practices which are illegal under UK law.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
In the United Kingdom, regulated healthcare professionals are required by law to maintain standards in competence, ethics, patient safety, and accountability. Failure to meet these standards can result in investigation, restrictions, suspension, or permanent removal from the register. Responsible employment practices are an important element in ensuring all those working in the research and innovation system can thrive and deliver high quality research.
Researchers funded through UK Research and Innovation (UKRI), National Institute for Health and Care Research (NIHR), and other publicly funded sources are expected to comply with the highest standards of research ethics and integrity, including responsible publication practices. Both UKRI and NIHR are signatories to the Concordat to Support Research Integrity.
The NIHR's support for the San Francisco Declaration on Research Assessment aligns with its dedication to research integrity, transparency, and fostering a culture where research excellence is measured in a more holistic and meaningful way.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of laboratory and record-keeping systems supporting Clozapine treatment, and whether they meet the standards expected for equivalent safety-critical medicines in physical healthcare.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England’s National Patient Safety Team collect records of all patient safety incidents recorded by National Health Service trusts via the Learn From Patient Safety Events service. These records are used to identify new and under-recognised risks to patient safety and to understand themes and trends. The insight generated informs work to improve patient safety across the NHS. Further information is available at the following link:
The safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources, including reports of suspected side effects through the Yellow Card Scheme, data from marketing authorisation holders, and research published in the scientific literature.
Each clozapine marketing authorisation holder operates a Patient Monitoring Scheme which focuses on the blood monitoring requirements for clozapine. However, regular contact with healthcare professionals caring for patients receiving clozapine has resulted in a high proportion of suspected side effects being reported through the Yellow Card scheme. These reports are published by the MHRA in the interactive drug analysis profile for clozapine, with further information avaiable at the following link:
https://yellowcard.mhra.gov.uk/idaps/CLOZAPINE
The Summary of Product Characteristics for clozapine outlines the monitoring requirements needed to minimise the risks of possible side effects for healthcare professionals. However, the MHRA does not regulate clinical practice or audit NHS record-keeping systems.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how learning from serious incidents involving accidental Clozapine withdrawal is being recorded and shared nationally across NHS mental health services.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Clozapine is used to treat people with schizophrenia in whom other medicines have not worked. It is also used to treat severe disturbances in the thoughts, emotions, and behaviour of people with Parkinson’s disease in whom other medicines have not worked.
The known side effects of clozapine are outlined in the product information, the Summary of Product Characteristics (SPC) for healthcare professionals, and the Patient Information Leaflet which is provided in each pack of the medicine. The SPC states that clozapine should be stopped in a number of clinical situations including after developing a low white blood cell count, fever above 38oC, high blood glucose, also known as hyperglycaemia, as well as jaundice or clinically relevant increases in liver enzymes. If clozapine is restarted it must be carefully titrated and monitoring requirements followed.
Inadvertent withdrawal of clozapine is an issue that is included in the National Health Service’s Time Critical Medicines Safety Improvement Programme, with further information avaiable at the following link:
https://www.sps.nhs.uk/articles/safer-use-of-time-critical-medicines-programme/
The programme is supporting over 50 NHS hospitals to improve the reliability of administration of Time Critical Medicines such as clozapine.
In July 2024 a thematic review of clozapine safety conducted in the North West of England was shared with the NHS England National Medication Safety Officer Network. This included a range of clozapine safety resources published online, such as:
- Managing the risks associated with patients prescribed clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-the-risks-associated-with-patients-prescribed-clozapine/;
- Clinical considerations for patients prescribed clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/clinical-considerations-for-patients-prescribed-clozapine/;
- Managing constipation in people taking clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-constipation-in-people-taking-clozapine/;
- Clozapine use in adults with swallowing difficulties, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/clozapine-use-in-adults-with-swallowing-difficulties/;
- Managing specific interactions with smoking, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-specific-interactions-with-smoking/; and
- Managing complexities of medication use across care boundaries, which includes a podcast on clozapine safety and which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-complexities-of-medication-use-across-care-boundaries/.
As with all medicines, the safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources. The MHRA is currently reviewing the blood monitoring requirements associated with clozapine.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Department has received formal representations from professional medical bodies regarding the PATHWAYS trial since ethical approval was granted.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what indemnity arrangements are in place for clinicians involved in prescribing puberty blockers under the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what role NHS England played in determining the eligibility criteria for children recruited into the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether Ministers approved the commencement of the PATHWAYS puberty blocker trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he plans to take to ensure that Parliament is provided with adequate opportunities for scrutinising progress and outcomes of the PATHWAYS trial while it is ongoing.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which international clinical guidelines were used in the design of the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what data sharing agreements are in place governing access to PATHWAYS trial participant data by external researchers or academic institutions.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.