Lord Kennedy of Southwark – 2015 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Lord Kennedy of Southwark on 2015-10-22.

To ask Her Majesty’s Government what action they are taking to ensure that all evidence, and not just scientific studies, is presented to the inquiry into the safety of hormone pregnancy tests.

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 To date, the MHRA has requested relevant published and unpublished information from all companies whose predecessors marketed HPTs and has conducted a search of the National Archives with a view to obtaining a complete set of historical documents relevant to this issue.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.