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Report of the Expert Working Group on Hormone Pregnancy Tests

Statement made on 15 November 2017

Statement UIN HCWS245


My hon. Friend the Parliamentary Under-Secretary of State for Health (Lord O'Shaughnessy) has made the following statement:

Today, the Commission on Human Medicines has published the report of its Expert Working Group on Hormone Pregnancy Tests. 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, either with regard to miscarriage, stillbirth or congenital anomalies.

In the UK, Hormone Pregnancy Tests first became available for diagnosing pregnancy in the 1950s. Between the 1950s and 1978, when Primodos was withdrawn from the market in the UK, a number of studies were published which investigated a possible link between women being given a Hormone Pregnancy Test to diagnose pregnancy and the occurrence of a range of congenital anomalies in the offspring.

Although there was never any reliable evidence that HPTs were unsafe, concern about this issue, coupled with the development of better pregnancy tests meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers.

The body of information subsequently accrued by the ‘Association for Children Damaged by Hormone Pregnancy Tests’ and other campaigners, led to a Parliamentary debate in 2014 during which the then Minister for Life Sciences, George Freeman MP, stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified.

The purpose of the review was to ascertain whether the totality of the available data, on balance, support a causal association between use of a Hormone Pregnancy Test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone or due to other factors.

An Expert Working Group of the Commission on Human Medicines was established in October 2015 to conduct the review with the benefit of up-to-date scientific expertise.

The Expert Working Group was subject to a strict conflict of interest policy and comprised experts from a broad range of specialisms, together with lay representation. The terms of reference of the Expert Working Group, were as follows:

  • To consider all available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy (in particular congenital anomalies, miscarriage and stillbirth) including consideration of any potential mechanism of action.

  • To consider whether the Expert Working Group’s findings have any implications for currently licensed medicines in the UK or elsewhere.

  • To draw any lessons for how drug safety issues in pregnancy are identified, assessed and communicated in the present regulatory system and how the effectiveness of risk management is monitored.

  • To make recommendations.

    The final report summarises the scientific evidence that was considered by the Expert Working Group, its conclusions on the evidence, and its recommendations. 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.

    In addition to the overall conclusion, the Expert Working Group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns with use of medicines in early pregnancy. These recommendations can be found in the report. The Medicines and Healthcare products Regulatory Agency will coordinate their implementation, in collaboration with relevant organisations; and the Commission on Human Medicines, together with its Expert Advisory Group on Medicines’ for Women’s Health, will ensure progress is regularly monitored.

    The evidence which has been reviewed by the Expert Working Group will be published in the New Year once it has been checked in line with the legal duties of data protection and confidentiality.

    I attach a copy of the report.

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Department of Health and Social Care

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This statement has also been made in the House of Lords

Department of Health
Report of the Expert Working Group on Hormone Pregnancy Tests
Lord O'Shaughnessy
Parliamentary Under-Secretary of State for Health
Conservative, Life peer
Statement made 15 November 2017