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 steps they are taking, if any, to fund independent scientific research into hormone pregnancy tests; and whether they are planning to set up an independent public inquiry into such tests.
Answered by Lord O'Shaughnessy
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was established in 2015 to consider all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Expert Working Group conducted a comprehensive, scientifically robust and independent review of all available scientific evidence relating to hormone pregnancy tests including the responses to a public call for evidence. In reaching its conclusion that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy, the Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy. The current focus of the Medicines and Healthcare products Regulatory Agency (MHRA) is on implementing these recommendations.
The Government’s priority, as always, is the safety of patients. While there are no plans to fund independent scientific research into hormone pregnancy tests (which have not been available since 1978), should any further evidence emerge of direct relevance to hormone pregnancy tests the MHRA will evaluate this. In addition, certain recommendations of the Expert Working Group’s review are anticipated to encourage relevant research into the safety of medicines in pregnancy.
Asked by: Maria Eagle (Labour - Garston and Halewood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will undertake an annual review of all congenital anomalies with the independent scientific advice of the Commission on Human Medicines, as recommended in the Report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests, published on 15 November 2017.
Answered by Steve Brine
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests made a number of forward-looking recommendations to further strengthen the systems in place for detecting, evaluating, and communicating risk with exposure to medicines in pregnancy. All suspected adverse drug reactions in pregnancy, including congenital anomalies, that are reported by healthcare professionals and women in the United Kingdom to the Medicines and Health products Regulatory Agency will be independently reviewed by experts. The findings and conclusions of the reviews will be published in the annual reports of the Commission on Human Medicines.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, pursuant to the Answer of 22 November 2017 to Question 112845, if he will meet with external experts on hormone pregnancy tests.
Answered by Steve Brine
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests included experts in a wide range of relevant scientific disciplines and took evidence from visiting experts. After consideration of a broad range of data, the consensus conclusion of Group members was that the available scientific evidence, taking all aspects into consideration, did not support a causal association between the use of hormone pregnancy tests during early pregnancy. This conclusion was endorsed by the Commission on Human Medicines which comprises independent scientific experts of international standing. There are no plans to meet other external experts.
Asked by: Robert Jenrick (Conservative - Newark)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what the Government's policy is on the conclusions of the Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, published in November 2017.
Answered by Steve Brine
The Commission on Human Medicines published the report of its Expert Working Group on Hormone Pregnancy Tests on 15 November 2017. This was the culmination of an extensive and thorough review of all the available relevant evidence on a possible association between Hormone Pregnancy Tests and adverse outcomes of pregnancy by a panel comprising independent experts of international standing in relevant scientific and medical specialisms.
The Expert Working Group’s overall finding, endorsed by the Commission on Human Medicines, was that the available scientific evidence, taking all aspects into consideration, did not support a causal association between the use of Hormone Pregnancy Tests, such as Primodos, during early pregnancy and adverse outcomes of pregnancy, including miscarriage, stillbirth or congenital anomalies. The Expert Working Group also made a number of important, forward-looking recommendations to further strengthen the systems in place for detecting, evaluating, managing and communicating safety concerns associated with use of medicines in early pregnancy.
Departmental ministers have accepted the report’s conclusions and recommendations. The focus is now on implementing these recommendations.
Asked by: Julie Elliott (Labour - Sunderland Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will bring forward proposals for a review of the findings of the Report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests, published in October 2017.
Answered by Steve Brine
The Commission on Human Medicines published the report of its Expert Working Group on Hormone Pregnancy Tests on 15 November 2017. Departmental ministers have accepted the report’s conclusions and recommendations.
Based on its extensive and thorough review, the Expert Working Group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a causal association between the use of Hormone Pregnancy Tests, such as Primodos, during early pregnancy and adverse outcomes of pregnancy, including miscarriage, stillbirth or congenital anomalies. In addition to the overall conclusion, the Expert Working Group has made a number of recommendations to safeguard future generations through further strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns associated with the use of medicines in early pregnancy.
All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms. There are no proposals for a review of the report’s findings and the Medicines and Healthcare products Regulatory Agency will now take forward the recommendations.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what meetings he has had with external experts on hormone pregnancy tests in each of the last 12 months.
Answered by Steve Brine
My Rt. hon. Friend the Secretary of State has not met with external experts on Hormone Pregnancy tests in the last 12 months. The Government committed to an independent review of the available evidence relating to Hormone Pregnancy Tests and the possible risk of birth defects in October 2014. The review was carried out by an Expert Working Group of the Commission on Human Medicines, the Government’s independent advisory body on medicines. Careful consideration was given to the membership of the Expert Working Group to make sure the panel was well qualified and of sufficient breadth of exercise to conduct a rigorous scientific review. The Expert Working Group was comprised of a Chair and 15 members who are experts in a wide range of relevant scientific disciplines. The membership of the Expert Working Group included expertise in: pharmacoepidemiology; toxicology; pharmacology; family planning; embryology; neonatal development; reproductive endocrinology; clinical genetics, gynaecology; obstetrics; perinatal epidemiology; paediatric epidemiology; and medical statistics.
The Expert Working Group on Hormone Pregnancy Tests (HPTs) invited seven external experts to present evidence for consideration during its review of the available evidence on a possible association between exposure to HPTs and adverse outcomes of pregnancy.
The report of the Expert Working Group was published on 15 November 2017. Based on this extensive and rigorous review, their overall conclusion was that, based on the totality of the data, the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what the timetable is for the Expert Panel Working Group Inquiry into hormone pregnancy tests to release its report.
Answered by Steve Brine
My Rt. hon. Friend the Secretary of State has not met with external experts on Hormone Pregnancy tests in the last 12 months. The Government committed to an independent review of the available evidence relating to Hormone Pregnancy Tests and the possible risk of birth defects in October 2014. The review was carried out by an Expert Working Group of the Commission on Human Medicines, the Government’s independent advisory body on medicines. Careful consideration was given to the membership of the Expert Working Group to make sure the panel was well qualified and of sufficient breadth of exercise to conduct a rigorous scientific review. The Expert Working Group was comprised of a Chair and 15 members who are experts in a wide range of relevant scientific disciplines. The membership of the Expert Working Group included expertise in: pharmacoepidemiology; toxicology; pharmacology; family planning; embryology; neonatal development; reproductive endocrinology; clinical genetics, gynaecology; obstetrics; perinatal epidemiology; paediatric epidemiology; and medical statistics.
The Expert Working Group on Hormone Pregnancy Tests (HPTs) invited seven external experts to present evidence for consideration during its review of the available evidence on a possible association between exposure to HPTs and adverse outcomes of pregnancy.
The report of the Expert Working Group was published on 15 November 2017. Based on this extensive and rigorous review, their overall conclusion was that, based on the totality of the data, the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Cabinet Office:
To ask the Prime Minister, what meetings she has had with (a) hon. Members and (b) external experts on (i) hormone pregnancy tests and (ii) the Expert Working Group on hormone pregnancy tests.
Answered by Theresa May
The Expert Working Group of the Commission on Human Medicines on hormone pregnancy tests is independent of Government. It published its report on Wednesday 15 November. The Department of Health is now focused on implementing the review’s recommendations to safeguard future generations by further strengthening the systems in place for detecting, evaluating and communicating safety concerns with use of medicines in pregnancy.
Asked by: Conor McGinn (Independent - St Helens North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what the criteria was for the issue of a confidentiality agreement with a Primodos patient; and if he will make a statement.
Answered by Steve Brine
We have interpreted that the Hon. Member’s question relates to confidentiality agreements for those who participated in the Expert Working Group on Hormone Pregnancy Tests.
Under the Human Medicines Regulations 2012, express restrictions are placed on the disclosure of any information by a person who obtains it by virtue of those Regulations (which includes those participating in meetings of the Commission on Human Medicines and its Expert Working Groups).
All participants of the Expert Working Group on Hormone Pregnancy Tests were required to sign a confidentiality declaration form to confirm their understanding that the paperwork, any other correspondence and discussions of the Group are strictly confidential, and must not be disclosed. Observers on the Expert Working Group, including patient representatives, were also asked to sign the form.
The report of the Group was published on 15 November 2017. All the supporting evidence, will be published once it has been reviewed in line with duties under data protection legislation, and common law duty of confidence.
Asked by: Lord Smith of Hindhead (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government when the expert working group report into Primodos is expected to be published.
Answered by Lord O'Shaughnessy
The report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests (including Primodos) is currently being finalised and is expected to be published before the end of autumn.