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 9 April 2019 to Question 239926 on Pregnancy Tests, for what reason previous studies were not considered robust; and what the extensive limitations were.

The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.

The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.

The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.

The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.