Asked by: Munira Wilson (Liberal Democrat - Twickenham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he plans to implement the recommendations outlined in the Cumberlege Review with respect to the drug Primodos.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Our sympathies remain with those who believe they were harmed by hormone pregnancy tests, such as Primodos.
Recommendation 4 of the Independent Medicines and Medical Devices Safety Review, also known as the Cumberlege Review, specifically mentions hormone pregnancy tests, recommending that separate redress schemes be set up for each of the interventions examined by the Review, namely hormone pregnancy tests, sodium valproate and pelvic mesh. As a follow up to this recommendation, the Patient Safety Commissioner was asked to investigate and provide advice on options for redress for those affected by sodium valproate and pelvic mesh. The Government is carefully considering the Patient Safety Commissioner’s recommendations.
The Patient Safety Commissioner was not asked to look at Primodos as part of this work, because the available scientific evidence does not support a causal association between the use of hormone pregnancy tests such as Primodos and adverse outcomes in pregnancy. The Government is committed to reviewing any new scientific evidence which may come to light.
Asked by: Laurence Turner (Labour - Birmingham Northfield)
Question to the Department of Health and Social Care:
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 Healthcare Products Regulatory Agency and (b) Commission on Human Medicines considered the findings of the Committee on Safety of Medicines study that began in 1969 as part of the recent review that is referred to in that Answer.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
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.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Baroness Merron on 1 July (HL8570), whether any scientific studies authored by Michael Briggs were included in the Expert Working Group review, published in November 2017.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
An Expert Working Group (EWG) of the Commission on Human Medicines reviewed the available evidence on the possible association between hormone pregnancy tests and adverse outcomes in pregnancy. Its review considered all available scientific evidence, including information collected from a public call for evidence.
The purpose of the EWG was to ascertain whether the available data could establish a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.
One publication by Briggs was considered as part of the review of non-clinical evidence of reproductive and developmental toxicity for norethisterone acetate and ethinylestradiol and is therefore referenced on page 97 of this review. This publication is not cited within the text of the report as it did not contribute towards the final paper and its conclusions.
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 hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.
The Medicines and Healthcare products Regulatory Agency remains committed to reviewing any new scientific data which becomes available following the conclusion of the EWG.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they plan to review the claims by Joanne Briggs that her father Michael Briggs, a scientist employed by Schering, had falsified his studies about the effects of Primodos, and whether they plan to take further action in response.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
An Expert Working Group (EWG) of the Commission on Human Medicines (CHM) reviewed the available evidence on the possible association between hormone pregnancy tests and adverse outcomes in pregnancy. Its review considered all available scientific evidence, including information collected from a public call for evidence.
The purpose of the EWG was to ascertain whether the available data could establish a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes. 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 hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.
The Medicines and Healthcare products Regulatory Agency (MHRA) committed to review any new scientific data which became available following the conclusion of the EWG. Accordingly, two new CHM EWGs were established to review two new studies of hormone pregnancy tests published in 2018. The reviews concluded that they did not present evidence that was sufficient or robust enough change the scientific position since the report of the EWG was published. The MHRA also sought a further independent scientific opinion on these two studies from the European Medicines Agency's Committee for Medicinal Products for Human Use, who concluded that they have no clinical implications.
In November 2024, the publication by Danielsson et al was reviewed by the MHRA and advice has been sought from the Government’s independent advisory body, the CHM. Following their review, the CHM concluded that a further review by an ad hoc EWG was not warranted at this time and supported the MHRA’s conclusion that no new evidence, with respect to a possible association between hormone pregnancy tests and adverse outcomes in pregnancy, was identified.
The MHRA remains committed to reviewing any new scientific evidence which may come to light.
Asked by: Kanishka Narayan (Labour - Vale of Glamorgan)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department plans to (a) launch a further review into and (b) consider the potential merits of (i) recognition and (ii) redress for people affected by the historic use of Primodos.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is sympathetic to the families who believe that they have suffered because of using hormone pregnancy tests.
An Expert Working Group of the Independent Commission on Human Medicines (CHM) reviewed the available scientific evidence in 2017 and concluded that the evidence does not support a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes. Following a review of the more recent evidence, the CHM concluded in November 2024 that it does not provide any new scientific evidence demonstrating that the medicinal components of hormone pregnancy tests could disrupt a pregnancy.
It is not currently the Government’s intention to review the findings of the Expert Working Group, however we are committed to reviewing any new scientific evidence which may come to light.
Because a causal link between hormone pregnancy tests and adverse outcomes in pregnancy has not been demonstrated, the previous administration did not ask the Patient Safety Commissioner to look at redress for hormone pregnancy tests as part of the Hughes Report.
Asked by: Jeremy Hunt (Conservative - Godalming and Ash)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he will implement the recommended compensation schemes for victims of (a) pelvic mesh implants, (b) sodium valproate, and (c) Primodos made by the Hughes report.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is carefully considering the valuable work done by the Patient Safety Commissioner and the resulting Hughes Report, which set out options for redress for those harmed by valproate and pelvic mesh. This is a complex area of work, involving several Government departments, and it is important that we get this right. We will be providing an update to the Patient Safety Commissioner’s report at the earliest opportunity.
The Patient Safety Commissioner was not asked to look at redress for hormone pregnancy tests as part of her recent report. The causal link between the use of hormone pregnancy tests during pregnancy and adverse outcomes in pregnancy has not been demonstrated. However, we are committed to reviewing any new scientific evidence that comes to light.
We remain hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reason Primodos was not within the terms of reference of the Hughes Report: options for redress for those harmed by valproate and pelvic mesh, published on 7 February 2024.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.
The previous administration did not ask the Patient Safety Commissioner, Dr Henrietta Hughes, to look at redress for hormone pregnancy tests as part of the Hughes Report, because a causal link between hormone pregnancy tests and adverse outcomes in pregnancy has not been demonstrated. An Expert Working Group of the independent Commission on Human Medicines reviewed the available scientific evidence in 2017 and concluded that it does not support a causal association. This position was reaffirmed in its most recent review in November 2024. However, we are committed to reviewing any new scientific evidence that comes to light.
Asked by: Anneliese Midgley (Labour - Knowsley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to help support people affected by Primodos in Knowsley constituency.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
While the Government is sympathetic to the families who believe that they have suffered because of using Hormone Pregnancy Tests, the currently available scientific evidence does not support a causal association between the use of Hormone Pregnancy Tests during early pregnancy and adverse pregnancy outcomes.
The Medicines and Healthcare Products Regulatory Agency has committed, together with the wider Government, to review any new scientific evidence which comes to light since the conclusions of the 2017 independent Expert Working Group convened by the Commission on Human Medicines.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 13 September 2024 to Question 4203 on Primodos: Research, when he expects the Medicines and Healthcare products Regulatory Agency to complete that review; and what steps he is taking to (a) manage potential conflicts of interest and (b) ensure transparency during the review process.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), together with the wider Government, are committed to reviewing any new scientific evidence since the conclusions of the 2017 independent Expert Working Group, convened by the Commission on Human Medicines (CHM).
As per the commitment to reviewing any new scientific evidence, the MHRA has reviewed the publication by Danielsson et al. For full transparency, the MHRA will present their review at the November 2024 CHM meeting. The meeting will have a number of invited experts, including the papers authors, who are invited to give a presentation on their paper and address any questions from the CHM. Mrs Marie Lyon has also been invited to participate as an expert patient, as a representative of the Association For Children Damaged by Hormone Pregnancy Tests. The CHM will give their opinion, and the MHRA will then act upon the CHM’s advice if required. Both the MHRA and the CHM have codes of conduct in order to manage potential conflicts of interest.
The MHRA have a Dealing with Staff Conflicts of Interest Policy, where staff must declare all relevant interests on appointment, when they arise and annually, so that they can be discussed, mitigated, or disposed of, or both, as required. Staff cannot hold direct financial interests in the pharmaceutical industry or healthcare, specifically medical device, industries.
The CHM has a Code of Practice on conflicts of interest which applies to chairs, members, co-opted members, and invited observers and experts. The annual declaration of interests made by all chairs and members are published on GOV.UK website. Declarations from members for the day, invited experts, and patient experts are published in the same way as permanent members of the CHM, on the GOV.UK website, and in the committee minutes for transparency reasons. Further information is available on the GOV.UK website, at the following link:
The minutes and outcome of the November CHM discussion will be communicated and made publicly available through the GOV.UK website, at the earliest opportunity.
Asked by: Darren Paffey (Labour - Southampton Itchen)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will (a) review evidence on the health impacts of Primodos and (b) make an assessment of the potential merits of introducing a financial redress scheme for people affected by Primodos.
Answered by Andrew Gwynne
We are hugely sympathetic to the families who believe that they have suffered because of using Hormone Pregnancy Tests (HPTs). Currently, the available scientific evidence does not support a causal association between the use HPTs during early pregnancy and adverse pregnancy outcomes.
The Medicines and Healthcare products Regulatory Agency, together with the wider Government, has committed to review any new scientific evidence which comes to light since the conclusions of the 2017 independent Expert Working Group convened by the Commission on Human Medicines.
Due to the unavailability of scientific evidence supporting a causal association between the use of HPTs and adverse pregnancy outcomes, options for financial redress have not been considered further.