Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what definition will be used by the Government to determine a serious shortage of a medicine that will be used to trigger a Serious Shortage Protocol for a medicine under the Human Medicines (Amendment) Regulations 2019.

The Department has well established processes to manage and mitigate the small number of medicine supply problems that may arise at any one time due to manufacturing or distribution issues and this has always been the case. The Department receives regular reports from the pharmaceutical industry about issues which may potentially interrupt the supply of medicines that may affect United Kingdom patients.

From January this year, it became a mandatory requirement that pharmaceutical companies must report this information to us in a timely manner.

A Serious Shortage Protocol (SSP) is an additional tool to manage and mitigate medicine shortages. It would only be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.

In the case of a serious shortage, a SSP would only be issued by Ministers if clinicians advised that it was appropriate and after discussion with the manufacturer and/or marketing authorisation holder.