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The review referenced in Question 31168 considered the 2023 publication by Danielsson et al only. The Medicines and Healthcare products Regulatory Agency’s (MHRA) assessment of this publication focussed on new data, which concerned transient embryonic hypoxia and teratogenicity in relation to oral hormone pregnancy tests (HPTs), and has been published...
The review referenced in Question 31168 considered the 2023 publication by Danielsson et al only. The Medicines and Healthcare products Regulatory Agency’s (MHRA) assessment of this publication focussed on new data, which concerned transient embryonic hypoxia and teratogenicity in relation to oral hormone pregnancy tests (HPTs), and has been published...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 3 March 2025 to Question 31168 on Primodos: Research and with reference to the oral contribution of Mr Roland Moyle on 26 May 1978, HC official record Volume 950, whether (a) the Medicines and...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 3 March 2025 to Question 31168 on Primodos: Research and with reference to the oral contribution of Mr Roland Moyle on 26 May 1978, HC official record Volume 950, whether (a) the Medicines and...
The review referenced in Question 31168 considered the 2023 publication by Danielsson et al only. The Medicines and Healthcare products Regulatory Agency’s (MHRA) assessment of this publication focussed on new data, which concerned transient embryonic hypoxia and teratogenicity in relation to oral hormone pregnancy tests (HPTs), and has been published at the following link:
This MHRA assessment was considered by the Commission on Human Medicines (CHM) in November 2024. A copy of the minutes of this CHM meeting is attached.
The study referenced by Mr Roland Moyle on 26 May 1978 is titled Maternal drug histories and congenital anomalies, and is authored by Greenberg G, Inman WHW, Weatherall, JAC et al. This was published in the British Medical Journal in October 1977, and is available at the following link:
https://www.bmj.com/content/2/6091/853.abstract
The original Expert Working Group (EWG) convened by the United Kingdom’s CHM to review all available evidence on the possible association between HPTs and adverse outcomes in pregnancy considered the study by Greenberg G referenced above as part of their review.
The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of HPTs during early pregnancy and adverse pregnancy outcomes. The EWG report on the use of HPTs and adverse effects relating to pregnancy, including possible birth defects, is published online, at the following link:
The MHRA remains committed to reviewing any new scientific data which becomes available following the conclusion of the EWG.
To ask the Secretary of State for Health and Social Care, when he plans to publish the (a) minutes and (b) outcome of the Commission on Human Medicines Antidepressant Risk Minimisation Expert Working Group meeting which took place on 1 May.
To ask the Secretary of State for Health and Social Care, when he plans to publish the (a) minutes and (b) outcome of the Commission on Human Medicines Antidepressant Risk Minimisation Expert Working Group meeting which took place on 1 May.
A public assessment report will be published following the advice of the Commission on Human Medicines (CHM) to the Medicines and Healthcare products Regulatory Agency (MHRA) after the next meeting of the Antidepressant Risk Minimisation Expert Working Group (EWG) in July 2025. The public assessment report will contain the minutes of all EWG meetings and the outcome of the CHM’s advice. It is anticipated that the public assessment report will be published by the MHRA in Autumn 2025.
To ask the Secretary of State for Health and Social Care, if he will publish the dates of the consultation period with pharmaceutical companies, as agreed at the Commission on Human Medicines Antidepressant Risk Minimisation Expert Working Group meeting on 1 May.
To ask the Secretary of State for Health and Social Care, if he will publish the dates of the consultation period with pharmaceutical companies, as agreed at the Commission on Human Medicines Antidepressant Risk Minimisation Expert Working Group meeting on 1 May.
The Medicines and Healthcare products Regulatory Agency (MHRA) will seek the advice of the independent Commission on Human Medicines (CHM) on the final recommendations of the Antidepressant Risk Minimisation Expert Working Group, following the next meeting in July 2025.
If the CHM advises the MHRA to request changes to the antidepressant product information, the MHRA will write to all of the pharmaceutical companies affected in accordance with standard timelines and procedures for requesting variations to product information.
To ask the Secretary of State for Health and Social Care, when the Medicines and Healthcare products Regulatory Agency will complete its consideration of the recommendations of the Commission on Human Medicines on the findings of the Danielsson et al on primodos.
To ask the Secretary of State for Health and Social Care, when the Medicines and Healthcare products Regulatory Agency will complete its consideration of the recommendations of the Commission on Human Medicines on the findings of the Danielsson et al on primodos.
The Medicines and Healthcare products Regulatory Agency (MHRA), together with wider Government, has committed to reviewing any new scientific evidence which comes to light.
The new publication by Danielsson et al has been reviewed by the MHRA, and advice has been sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM), who have provided their independent expert advice on our assessment of whether the findings of the latest publication justify a further review. The MHRA will consider the recommendations given by the CHM before deciding whether any further action is warranted.
The minutes of the November CHM meeting will be made publicly available through the GOV.UK website at the earliest opportunity.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 18 November 2024 to Question 12696 on Primodos: Research, when the minutes and outcome of the November Commission on Human Medicines discussion will be published.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 18 November 2024 to Question 12696 on Primodos: Research, when the minutes and outcome of the November Commission on Human Medicines discussion will be published.
The Medicines and Healthcare products Regulatory Agency (MHRA), together with the wider Government, have committed to reviewing any new scientific evidence which comes to light.
The new publication by Danielsson et al has been reviewed by the MHRA and advice has been sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM), who have provided their independent expert advice on our assessment of whether the findings of the latest publication justify a further review. The MHRA will consider the recommendations given by the CHM before deciding whether any further action is warranted.
The minutes of the November CHM meeting will be made publicly available through the GOV.UK website at the earliest opportunity.
To ask the Secretary of State for Health and Social Care, what (a) medical professionals, (b) charities, (c) organisations and (d) other groups the Commission on Human Medicines consulted on the provision of puberty blockers.
To ask the Secretary of State for Health and Social Care, what (a) medical professionals, (b) charities, (c) organisations and (d) other groups the Commission on Human Medicines consulted on the provision of puberty blockers.
The Government’s response to the targeted consultation on proposed changes to the availability of puberty blockers was published on 11 December 2024, and details the individuals and organisations with which the Commission on Human Medicines consulted. It is available at the following link:
For those who are already on puberty blockers, there is an immediate withdrawal. But I hope that what I have outlined on mental health support covers all the areas the noble Baroness, and indeed all of us, are concerned about. The approach is as compressive as possible, and the new...
For those who are already on puberty blockers, there is an immediate withdrawal. But I hope that what I have outlined on mental health support covers all the areas the noble Baroness, and indeed all of us, are concerned about. The approach is as compressive as possible, and the new...
I thank the noble Baroness for bringing her expertise directly into the Chamber. We are very glad that she is in the House to do so, and she has actually answered a number of the points better than I ever could.
I will emphasise one point that I am particularly interested...
I thank the noble Baroness for bringing her expertise directly into the Chamber. We are very glad that she is in the House to do so, and she has actually answered a number of the points better than I ever could.
I will emphasise one point that I am particularly interested...
I understand the point my noble friend rightly raises, and I emphasise again that what matters here are safety considerations—particularly when we are talking about children and young people—
but also the evidence in respect of treatments, that there should be the prescription only of medication which is safe and...
I understand the point my noble friend rightly raises, and I emphasise again that what matters here are safety considerations—particularly when we are talking about children and young people—
but also the evidence in respect of treatments, that there should be the prescription only of medication which is safe and...
I do not recognise the last point that the noble Baroness made about the time. The aim is to start recruiting participants in spring next year and, as I mentioned, the National Institute for Health and Care Research is working with NHS England to develop the clinical trials. They are...
I do not recognise the last point that the noble Baroness made about the time. The aim is to start recruiting participants in spring next year and, as I mentioned, the National Institute for Health and Care Research is working with NHS England to develop the clinical trials. They are...
I very much welcome the generous and supportive comments of the noble Baroness, Lady Fox, in respect of the Secretary of State’s Statement. I am grateful for those. I note that she finds the reference to “uncapped” scary. I presented it as the way to gather the widest amount of...
I very much welcome the generous and supportive comments of the noble Baroness, Lady Fox, in respect of the Secretary of State’s Statement. I am grateful for those. I note that she finds the reference to “uncapped” scary. I presented it as the way to gather the widest amount of...
My noble friend is right to raise the second point. It is a whole range of interventions, and that is certainly something that we have very much in mind for consideration, for the reasons that we have heard in the Chamber this evening and the points that my noble friend...
My noble friend is right to raise the second point. It is a whole range of interventions, and that is certainly something that we have very much in mind for consideration, for the reasons that we have heard in the Chamber this evening and the points that my noble friend...
In view of what the noble Baroness said, it is quite important to consider that the children and young people’s gender services waiting list currently has 6,237 people on it. I certainly agree that waiting lists for these services are too long. We are committed to changing that, which is...
In view of what the noble Baroness said, it is quite important to consider that the children and young people’s gender services waiting list currently has 6,237 people on it. I certainly agree that waiting lists for these services are too long. We are committed to changing that, which is...
My Lords, I echo the thanks given to the Secretary of State for his careful and scientific approach to this issue and for his very sensitive Statement in the other place.
It might be helpful to elaborate on just one or two of the points that have been raised, particularly the...
My Lords, I echo the thanks given to the Secretary of State for his careful and scientific approach to this issue and for his very sensitive Statement in the other place.
It might be helpful to elaborate on just one or two of the points that have been raised, particularly the...
My Lords, given that puberty blockers almost invariably lead to cross-sex hormones, can the Minister explain why the proposed trial cannot study those who have already used or are using puberty blockers, rather than starting with a new cohort of children? Given that the trial will look at the long-term...
My Lords, given that puberty blockers almost invariably lead to cross-sex hormones, can the Minister explain why the proposed trial cannot study those who have already used or are using puberty blockers, rather than starting with a new cohort of children? Given that the trial will look at the long-term...
My Lords, I thank the Minister for the Statement and the right honourable Secretary of State for the careful and sensitive way in which he delivered the Statement in the other place. In line with my right honourable friend the shadow Secretary of State in the other place, from these...
My Lords, I thank the Minister for the Statement and the right honourable Secretary of State for the careful and sensitive way in which he delivered the Statement in the other place. In line with my right honourable friend the shadow Secretary of State in the other place, from these...
My Lords, on these Benches we welcome the tone of the Secretary of State’s Statement. I have often said that there are many ways of being human. Growing up can often be a very trying time for teenagers. How much more difficult, then, for those young people with gender distress...
My Lords, on these Benches we welcome the tone of the Secretary of State’s Statement. I have often said that there are many ways of being human. Growing up can often be a very trying time for teenagers. How much more difficult, then, for those young people with gender distress...