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.

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.