Asked by: Ed Davey (Liberal Democrat - Kingston and Surbiton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she will reassess the findings of the Expert Working Group review on Hormone Pregnancy Tests.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We have no plans to do so.
Asked by: Dan Carden (Labour - Liverpool, Walton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if she will commission an independent review of the report by the Expert Working Group of the Commission on Human Medicines on Hormone Pregnancy Tests, published on 15 November 2017.
Answered by Caroline Johnson
We have no plans to do so.
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 will publish all the documents they hold relating to victims of Primodos.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
All documents relating to hormone pregnancy tests, such as Primodos, other than those subject to legal privilege, have been published in an online only format at GOV.UK.
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 are supporting the pharmaceutical company Bayer in seeking to strike down an attempt by victims of Primodos to have their case heard; if so, why; and whether they will seek to establish an independent mediation process to ascertain whether there is a causal link between Primodos and birth defects.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is, with others, defending court proceedings which were issued in December 2019 by claimants who contend that hormone pregnancy tests (HPTs), such as Primodos, caused birth defects.
The Department has made an application to strike out the claim by individuals which allege that HPTs caused them harm, which is due to be heard in May 2023. The scientific evidence has been reviewed on a number of occasions and most recently by the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests. The Expert Working Group concluded that the available scientific evidence did not support a causal association. It is therefore not considered appropriate to establish an independent mediation process.
Asked by: Peter Dowd (Labour - Bootle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make it his policy to implement a compensation framework for people who have experienced harm as a result of Primodos.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government’s response to the Independent Medicines and Medical Devices Safety Review (IMMDS) was published on 21 July 2021. We did not accept the report’s fourth recommendation, which called for separate redress schemes should be set up for hormone pregnancy tests such as Primodos, sodium valproate and pelvic mesh
Our priority is to make medicines and devices safer. The Government’s response sets out the changes in place since the IMMDS Review’s report was published and further action we will take to implement the recommendations accepted and to improve patient safety.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to reconsider their response to the recommendation in the report of the Independent Medicines and Medical Devices Safety Review First do no harm, published on 8 July 2020, that separate schemes should be set up to meet the cost of providing additional care and support to those who have experienced avoidable harm from hormone pregnancy tests, valproate and pelvic mesh interventions.
Answered by Lord Kamall
The Government did not accept this recommendation and there are no plans to reconsider this response. Our priority is to make medicines and devices safer and we are pursuing a wide range of activity to further this aim. The response explains the changes that have been put in place since the Independent Medicines and Medical Devices Safety Review report’s publication and the further action the Government will take to implement the recommendations accepted and to improve patient safety.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions his Department had with Her Majesty's Treasury, prior to the publication of the Government response to the Report of the Independent Medicines and Medical Devices Safety Review on 26 July 2021, on setting up a redress scheme to meet the cost of providing additional care and support to people who have experienced avoidable harm as a result of (a) hormone pregnancy tests, (b) sodium valproate and (c) pelvic mesh.
Answered by Nadine Dorries
The Department engaged with HM Treasury on redress prior to cross-Government approval of the response to the Independent Medicines and Medical Devices Safety Review.
Asked by: Daisy Cooper (Liberal Democrat - St Albans)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Written Statement of 11 January 2021, Update on the Government’s response to the Independent Medicines and Medical Devices Safety Review, HCWS692, when he plans to complete his consideration of the recommendation for a redress scheme for people affected by (a) hormone pregnancy tests, (b) sodium valproate and (c) pelvic mesh; and if he will make a statement.
Answered by Nadine Dorries
We will respond further to the report of the Review later in 2021.
Asked by: Diana Johnson (Labour - Kingston upon Hull North)
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 17 May 2021 to Question 638, on Independent Review, what assessment the Government has made of the causal association between (a) Thalidomide and (b) oral hormone pregnancy tests with congenital malformations; and what comparative assessment the Government has made of the potential merits of awarding financial support to people affected by (a) Thalidomide and (b) oral hormone pregnancy tests.
Answered by Nadine Dorries
Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. Many lines of evidence have confirmed the causal link of exposure to thalidomide in pregnancy with congenital malformations. Consequently, thalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the Pregnancy Prevention Programme are met. The evidence for a possible causal association between hormone pregnancy tests (HPTs) and birth defects was considered by an Expert Working Group of the Commission on Human Medicines which published its findings on 15 November 2017. Based on this review, the Expert Working Group concluded that based on the totality of the data, the scientific evidence does not support a causal association between the use of HPTs and birth defects or miscarriage.
Work is ongoing to consider recommendation 4 of the Independent Medicines and Medical Devices Safety Review report, which included a proposed redress scheme for hormone pregnancy tests. This work includes looking at a range of existing schemes, including for thalidomide.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what representations they have received (1) from the Association for Children Damaged by Hormone Pregnancy Tests on behalf of families affected by Primados, and (2) following the report of the Independent Medicines and Medical Devices Safety Review First do no harm, published on 8 July; and when they intend to respond to any such representations.
Answered by Lord Bethell
On behalf of affected families, the Chair of the Association for Children Damaged by Hormone Pregnancy Tests (HPTs) attended every meeting of the Commission on Human Medicines’ Expert Working Group on HPTs and was invited to discuss their draft recommendations and give a statement to the Commission on the draft report of the Group. In addition, 13 affected families gave their personal experiences with Primodos to the Expert Working Group. Since publication of the report of the Independent Medicines and Medical Devices Safety Review, we have received a letter from the Chair of the Association for Children Damaged by Hormone Pregnancy Tests and will be responding shortly.
The Independent Medicines and Medical Devices Safety Review published its report on 8 July and all of its recommendations will be considered carefully. The Government will provide an update in due course.