Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his (a) Ministers and (b) officials have had with the (i) Medicines and Healthcare Regulatory Agency and (ii) members of the Expert Working Group on the review of hormone pregnancy tests (primodos) on why that Working Group changed the terms for that review from looking for an association to looking for a causal link as to the effect of the drugs concerned on the women it was given to.

The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.

Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.

In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.