Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they plan to review the claims by Joanne Briggs that her father Michael Briggs, a scientist employed by Schering, had falsified his studies about the effects of Primodos, and whether they plan to take further action in response.

An Expert Working Group (EWG) of the Commission on Human Medicines (CHM) reviewed the available evidence on the possible association between hormone pregnancy tests and adverse outcomes in pregnancy. Its review considered all available scientific evidence, including information collected from a public call for evidence.

The purpose of the EWG was to ascertain whether the available data could establish a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes. The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of hormone pregnancy tests during early pregnancy and adverse pregnancy outcomes.

The Medicines and Healthcare products Regulatory Agency (MHRA) committed to review any new scientific data which became available following the conclusion of the EWG. Accordingly, two new CHM EWGs were established to review two new studies of hormone pregnancy tests published in 2018. The reviews concluded that they did not present evidence that was sufficient or robust enough change the scientific position since the report of the EWG was published. The MHRA also sought a further independent scientific opinion on these two studies from the European Medicines Agency's Committee for Medicinal Products for Human Use, who concluded that they have no clinical implications.

In November 2024, the publication by Danielsson et al was reviewed by the MHRA and advice has been sought from the Government’s independent advisory body, the CHM. Following their review, the CHM concluded that a further review by an ad hoc EWG was not warranted at this time and supported the MHRA’s conclusion that no new evidence, with respect to a possible association between hormone pregnancy tests and adverse outcomes in pregnancy, was identified.

The MHRA remains committed to reviewing any new scientific evidence which may come to light.