Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what the criteria was for the issue of a confidentiality agreement with a Primodos patient; and if he will make a statement.

We have interpreted that the Hon. Member’s question relates to confidentiality agreements for those who participated in the Expert Working Group on Hormone Pregnancy Tests.

Under the Human Medicines Regulations 2012, express restrictions are placed on the disclosure of any information by a person who obtains it by virtue of those Regulations (which includes those participating in meetings of the Commission on Human Medicines and its Expert Working Groups).

All participants of the Expert Working Group on Hormone Pregnancy Tests were required to sign a confidentiality declaration form to confirm their understanding that the paperwork, any other correspondence and discussions of the Group are strictly confidential, and must not be disclosed. Observers on the Expert Working Group, including patient representatives, were also asked to sign the form.

The report of the Group was published on 15 November 2017. All the supporting evidence, will be published once it has been reviewed in line with duties under data protection legislation, and common law duty of confidence.