Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions he has had with the Medicines and Healthcare products Regulatory Agency on encouraging manufacturers to apply for UK licenses for Hormone Replacement Therapy implants.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department have kept ministers informed of the ongoing issues in the manufacturing of unlicenced products used as medicines for hormone replacement therapy (HRT) implants.

Regular discussions have been held with the importer of the unlicenced medicines, and the Medicines Supply team in the Department are actively looking at licenced alternatives to ensure ongoing supply.

A medicine can only become licensed if an application is made for such a licence, usually by the manufacturer, and the MHRA is only able to grant a marketing authorisation after the supporting data has been assessed to demonstrate its quality, safety, and efficacy for the conditions it is intended to treat, and to confirm that it has an acceptable balance of risk and benefit. In our role as the medicines regulator, we are not in a position to solicit for new product licence applications.

However, the MHRA welcomes marketing authorisation applications for HRT implants and has processes in place to review applications as soon as they are received. In addition, manufacturers can seek scientific advice on their product from the MHRA at any stage of development.