Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what progress has been made by his Department in encouraging more reclassification applications to the Medicines and Healthcare products Regulatory Agency (MHRA); whether reclassification applications will form part of the MHRA's forthcoming strategy; and what assessment he has made of the potential impact of reclassification applications on (a) the NHS, (b) patients and (c) the Exchequer.

The Government supports the reclassification of medicines where it is safe and appropriate to do so, as this can improve patient access and support selfcare while maintaining high standards of public health protection. The Medicines and Healthcare products Regulatory Agency (MHRA) actively engages with industry to encourage well evidenced reclassification applications and has updated its guidance and processes to provide greater clarity and efficiency.

Reclassification forms part of the MHRA’s wider strategic work to support proportionate regulation and improve access to medicines, including through closer engagement with industry and the use of scientific advice to support high quality applications.

Where successful, reclassification can benefit the National Health Service by reducing pressure on primary care services, enable patients to access appropriate treatments more conveniently through pharmacies or over the counter supply, and deliver wider economic benefits by supporting selfcare and reducing unnecessary healthcare utilisation. Each application is assessed on its individual merits to ensure that any reclassification maintains patient safety and delivers overall public benefit.

However, reclassification is not appropriate in all circumstances. In particular, where the need for ongoing clinical oversight remains important, or where cost or ability to pay could create barriers to equitable access for some patients, prescription supply through the NHS may remain the most appropriate route. Consideration of patient affordability and health inequalities forms part of the overall assessment of whether reclassification is in the public interest.