Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the informal consultation with stakeholder representative bodies on changes to the Human Medicines Regulation 2012 to ensure the continuity of supply of medicines (including in a no deal Brexit), what the (a) process and (b) governance arrangements will be for protocols to be developed and signed off centrally by clinicians.

The Department has well-established governance processes and arrangements for managing medicine shortages in collaboration with manufacturers and suppliers, clinicians and the National Health Service and the Medicines and Healthcare products Regulatory Agency (MHRA). A serious shortage protocol is only one of the tools that can be used to manage shortages. This protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder when other mitigation measures have been exhausted. Work on operationalising the serious shortage legislation, including the governance processes is ongoing, including the creation of a national, clinically-chaired group advising Ministers and national oversight at senior doctor level. The operation of the serious shortage protocol legislation will be reviewed one year after the first protocol has been issued.