Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of providing support to the Medicines and Healthcare products Regulatory Agency in reviewing (a) guidance and (b) regulations for the (i) licensing and (ii) packaging of medicines to ensure their safe use by blind and partially sighted people.

The Medicines and Healthcare products Regulatory Agency (MHRA) already has provision in the current Human Medicines Regulations 2012 No 1916 legislation, to ensure the licensing and packaging of medicines are safe for use by blind and partially sighted people. These require manufacturers of medicines to include braille on their packaging of medicinal products, so that those who are partially sighted or who are blind can effectively identify the product they have been prescribed and dispensed.

They also require medicine manufacturers to provide an alternative version of the patient information leaflet (PIL), should the paper version contained in the box not be suitable in meeting the patients’ needs. These alternative versions may include braille or audio versions of the PIL. The MHRA’s best practice guidance also provides manufacturers with guidance on how to ensure they meet the requirements of the legislation.

The MHRA recognises that there is opportunity to improve patient information based upon user research, to ensure it fulfils the needs of this patient group and others. They are also committed to embedding patient voices across the regulatory pathways as part of their Patient Involvement Strategy 2021. The current strategy is also being refreshed for 2026 re-launch.