Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when his Department will publish the criteria for determining orphan designation for medicines after the transition period; and whether he plans to consult with (a) patient groups, (b) industry and (c) other relevant stakeholders to help inform this criterion.

The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 1 October 2020 on how orphan designation for medicines will be managed after the transition period on our website.

The Department and MHRA have held a series of engagement sessions which were open to all our stakeholders to inform on how medicines will be regulated including such medicines after the end of the transition period.