Asked by: Louise Ellman (Independent - Liverpool, Riverside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what progress is being made on the inquiry into the Primodos hormone-based pregnancy test; and when he plans to publish the report.
Answered by Steve Brine
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 the year.
Asked by: Chris Ruane (Labour - Vale of Clwyd)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what recent estimate he has made of the number of people who were affected by the hormone pregnancy testing drug Primodos.
Answered by Steve Brine
The evidence for a possible causal association between Hormone Pregnancy Tests (HPTs, including Primodos) and birth defects is still under consideration by the Expert Working Group of the Commission on Human Medicines on HPTs and so the number of people who may have been affected by Primodos has not been estimated.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether the Expert Working Group on Hormonal Pregnancy Tests will review (1) the terms of reference of (a) the Committee on the Safety of Medicines, and (b) the Metabolic Research Unit, when determining what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy, (2) the need to assemble and assess reports of adverse reactions to drugs trials, and (3) how ministers should be advised of the outcomes of those trials.
Answered by Lord O'Shaughnessy
One of the terms of reference of the Expert Working Group on Hormonal Pregnancy Tests is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. The regulatory, legal and social landscape has changed significantly since hormonal pregnancy tests were on the market; many of these changes have been driven by previous experience. The Group will consider the processes and tools that were available to the United Kingdom regulator when hormonal pregnancy tests were on the market and make recommendations for any changes necessary to further improve the capability of current regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. This will include all aspects of medicines regulation, from the assessment of safety pre-authorisation to communication of an identified risk.
There has been continued engagement with the Association for Children Damaged by Hormonal Pregnancy Tests throughout the Expert Working Group review process. I am meeting the All Party Parliamentary Group on Hormone Pregnancy Tests and representatives of the Association in the near future.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether they will meet with Marie Lyon and representatives of the Primodos victims support group.
Answered by Lord O'Shaughnessy
One of the terms of reference of the Expert Working Group on Hormonal Pregnancy Tests is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. The regulatory, legal and social landscape has changed significantly since hormonal pregnancy tests were on the market; many of these changes have been driven by previous experience. The Group will consider the processes and tools that were available to the United Kingdom regulator when hormonal pregnancy tests were on the market and make recommendations for any changes necessary to further improve the capability of current regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. This will include all aspects of medicines regulation, from the assessment of safety pre-authorisation to communication of an identified risk.
There has been continued engagement with the Association for Children Damaged by Hormonal Pregnancy Tests throughout the Expert Working Group review process. I am meeting the All Party Parliamentary Group on Hormone Pregnancy Tests and representatives of the Association in the near future.
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 funding they are providing to researchers based in (1) Cambridge, and (2) Aberdeen, who are examining the composition of the drug Primodos and its likely effects on the child in the womb.
Answered by Lord O'Shaughnessy
An Expert Working Group of the Commission on Human Medicines is conducting a comprehensive scientific review on the evidence for a possible causal association between Hormone Pregnancy Tests (HPTs), including Primodos, and birth defects. Any important new evidence identified in the Sky News documentary will be reviewed by the Medicines and Healthcare products Regulatory Agency and provided to the Expert Working Group for their consideration and advice.
While the evidence for any association between HPTs and congenital defects is still under consideration it would be premature to comment on the need for a public inquiry.
The Government is not providing any funding to researchers in Cambridge or Aberdeen who are examining the composition of the drug Primodos and its likely effects on the child in the womb.
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 assessment they have made of the Sky News documentary <i>Primodos: The Secret Drugs Scandal</i>; and whether they will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety.
Answered by Lord O'Shaughnessy
An Expert Working Group of the Commission on Human Medicines is conducting a comprehensive scientific review on the evidence for a possible causal association between Hormone Pregnancy Tests (HPTs), including Primodos, and birth defects. Any important new evidence identified in the Sky News documentary will be reviewed by the Medicines and Healthcare products Regulatory Agency and provided to the Expert Working Group for their consideration and advice.
While the evidence for any association between HPTs and congenital defects is still under consideration it would be premature to comment on the need for a public inquiry.
The Government is not providing any funding to researchers in Cambridge or Aberdeen who are examining the composition of the drug Primodos and its likely effects on the child in the womb.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government, further to the Written Answers by Earl Howe on 26 October 2010 (HL2589, HL2591, HL2592, and HL2593) concerning the drug Primodos, and to the remarks by the Parliamentary Under Secretary of State for Health on 23 October 2014 (HC Deb 1139) concerning oral hormone pregnancy tests, and in the light of the Sky News documentary <i>Primodos: The Secret Drugs Scandal</i>, what progress has been made on the independent review of the papers and evidence relating to oral hormone pregnancy tests; what assessment that review has made of the decision by the Committee on Safety of Medicines to ask drug companies to stop promoting pregnancy test drugs to doctors in 1969 but not to advise doctors not to use such drugs until 1975; and whether that review will examine the allegations made in the Sky News documentary, in particular (1) that no toxicology or testing was undertaken prior to the drug Primodos being licensed, (2) that Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and (3) that there may have been collusion between the drug manufacturer and the regulatory bodies.
Answered by Lord O'Shaughnessy
Primodos, a hormonal pregnancy test, first became available in the 1950s. At that time there were no legal requirements on companies to ensure that marketed medicines met appropriate standards of safety, quality and efficacy and a licence to market was not required. Any studies performed on a medicine prior to its use were at the discretion of the company. The Medicines Act came into force in 1971.
The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests, adopted by its members and agreed with by the chair of the main patient association in her role as an ‘observer’ on the Group, are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy (particularly birth defects, miscarriages and stillbirths). The Group’s terms of reference also include what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.
Asked by: Stephen Kinnock (Labour - Aberavon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what representations he has received on evidence that was made available to the Government on the dangers of the pregnancy testing drug Primodos in 1967; and what steps he has taken as a result of those representations.
Answered by Baroness Blackwood of North Oxford
The Government has maintained an ongoing and close dialogue with campaigners over the course of the last eight years, involving face to face meetings and extensive correspondence. As a result of these discussions, the Government committed to an independent review of all the evidence relating to a possible link between hormone pregnancy tests and adverse effects on pregnancy. An ad-hoc Expert Working Group of the Commission on Human Medicines is conducting this review and has so far met on five occasions. It is anticipated that the review will be complete early in 2017, at which time a report of the Group’s findings will be published.
The Government remains committed to open engagement on this important issue.
Asked by: Louise Ellman (Independent - Liverpool, Riverside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether he plans to alter the terms of reference of the Expert Working Panel Group Inquiry into Primodos.
Answered by Baroness Blackwood of North Oxford
The terms of reference of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests were reviewed by the Group at their first meeting on 14 October 2015, endorsed by the Commission on Human Medicines and formally adopted by all members, invited experts and observers of the Expert Working Group at their second meeting on 4 December 2015.
On 13 October 2016 at a Backbench Business Committee debate secured by the All-Party Parliamentary Group (APPG) on Hormone Pregnancy Tests, the Government committed to respond in detail to the concerns raised by the APPG, which include the terms of reference of the Expert Working Group on Hormone Pregnancy Tests, and to then meet with the APPG to discuss these concerns.
Asked by: Lord Kennedy of Southwark (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government how people and organisations can make representations to the inquiry into the safety of hormone pregnancy tests.
Answered by Lord Prior of Brampton
The terms of reference for the inquiry into the safety of Hormone Pregnancy Tests (HPTs) state that the Expert Working Group (EWG) of the Commission on Human Medicines will consider all available evidence on the possible association between exposure in pregnancy to HPTs and adverse outcomes in pregnancy (in particular congenital anomalies, miscarriage and stillbirth). This will include scientific studies as well as wider sources of evidence.
The Medicines and Healthcare products Regulatory Agency (MHRA) is providing the secretariat to the review and is compiling all the available information. To date, the MHRA has requested relevant published and unpublished information from all companies whose predecessors marketed HPTs and has conducted a search of the National Archives with a view to obtaining a complete set of historical documents relevant to this issue. The MHRA will also search for all relevant published literature and review all suspected adverse drug reactions that have been submitted in association with HPTs in the United Kingdom. All of this information will be made available to the EWG.
Interested individuals and organisations were invited to provide any information relevant to a possible association between the use of oral HPTs and adverse outcomes in pregnancy through a public call for evidence between 25 March and 30 June 2015. In addition, the EWG will hear evidence from a number of individuals who feel their lives have been adversely affected by HPTs.
The report of the review and all documents will be made public subject to the usual legal requirements.