Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he has taken to ensure the (a) impartiality and (b) independence of panels members on the Commission on Human Medicines’ independent scientific review of the publication by Professor Carl Heneghan into hormone pregnancy tests.

Since publication of the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests (HPTs) the Government has committed to review any important new evidence that arises. In response to publication of the study by Heneghan et al. the Commission on Human Medicines convened an Expert Group to advise on the suitability and robustness of the methodology (including the selection and application of the data quality score) and any clinical implications.

To ensure impartiality none of the members of the Group was involved in the previous review by the Expert Working Group on HPTs. A specific conflict of interest policy was developed and all participants were required to complete and sign a declaration of interests form. Participants were asked to declare personal or non-personal interests in the companies who marketed HPTs or whose predecessors marketed them, current or previous involvement in any studies or reviews on HPTs, the expression in public of a strong opinion about HPTs or any of the companies that produced them, and direct or indirect involvement with, or peer review of, the publication by Heneghan et al. The conflict of interest policy and declarations of participants will be made public in due course.

For complete transparency the meeting was observed by the Chair of the Association for Children Damaged by HPTs, an advocate for those affected by thalidomide, a Lay representative and a representative from the Independent Medicines and Medical Devices Safety Review.

In parallel, the European Medicines Agency is conducting an independent review of the publication by Heneghan et al. Both reviews are ongoing, and we expect the conclusions to be made public within a month of their completion, likely to be May 2019.