Primodos, a hormonal pregnancy test, first became available in the 1950s. At that time there were no legal requirements on companies to ensure that marketed medicines met appropriate standards of safety, quality and efficacy and a licence to market was not required. Any studies performed on a medicine prior to its use were at the discretion of the company. The Medicines Act came into force in 1971.
The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests, adopted by its members and agreed with by the chair of the main patient association in her role as an ‘observer’ on the Group, are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy (particularly birth defects, miscarriages and stillbirths). The Group’s terms of reference also include what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.