Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when his Department plans to publish its consultation on the regulation of orphan drugs after the UK leaves the EU.

The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched in October 2018 a consultation on the regulation of medicines in the event of a ‘no deal’ exit, which included the proposed UK approach to the regulation of orphan medicines post-exit, including on incentives to encourage such medicines onto the UK market. Following this consultation, the MHRA, on 3 January 2019, published guidance on the UK proposed arrangements for the regulation of orphan medicines, in the event of a ‘no deal’ exit. This can be accessed at the following link:

https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal