Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential effect of the UK leaving the EU without a deal on the regulatory processes for new medicines for rare conditions.

The Medicines and Healthcare products regulatory Agency (MHRA), as with all of Government has been working hard to ensure that the United Kingdom is fully prepared for European Union exit under any circumstance. The potential effect that the UK leaving the EU without a deal will have on the regulatory processes for new medicines for rare conditions is being mitigated with clear guidance and close engagement with industry to ensure plans are relevant and fit for purpose.

Following a public consultation last year, the MHRA has legislated to ensure a smooth transition to national provisions for human medicines, including those for rare diseases. Indeed, for medicines for rare diseases the UK will offer incentives, some fees will be waived, with others fully or partially refunded, to encourage the development and marketing of such medicines.