Question to the Department of Health and Social Care:

To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether the Expert Working Group on Hormonal Pregnancy Tests will review (1) the terms of reference of (a) the Committee on the Safety of Medicines, and (b) the Metabolic Research Unit, when determining what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy, (2) the need to assemble and assess reports of adverse reactions to drugs trials, and (3) how ministers should be advised of the outcomes of those trials.

One of the terms of reference of the Expert Working Group on Hormonal Pregnancy Tests is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. The regulatory, legal and social landscape has changed significantly since hormonal pregnancy tests were on the market; many of these changes have been driven by previous experience. The Group will consider the processes and tools that were available to the United Kingdom regulator when hormonal pregnancy tests were on the market and make recommendations for any changes necessary to further improve the capability of current regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy. This will include all aspects of medicines regulation, from the assessment of safety pre-authorisation to communication of an identified risk.

There has been continued engagement with the Association for Children Damaged by Hormonal Pregnancy Tests throughout the Expert Working Group review process. I am meeting the All Party Parliamentary Group on Hormone Pregnancy Tests and representatives of the Association in the near future.