Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of levels of pancreatic enzyme replacement therapy, including Creon, on patient health outcomes.

The Department has made no formal assessment of the potential impact of levels of pancreatic enzyme replacement therapy (PERT) on health outcomes. However, the Department engages routinely with a range of representatives including local and regional pharmacy leads and patient charities to ensure that management strategies are improving access to PERT.

The Department is aware of ongoing intermittent supply issues with PERT, including Creon capsules. Supplies of Creon and other licensed alternatives have improved in the past year, and specialist importers have sourced unlicensed stock to assist in covering the remaining gap in the market. We continue to work closely with the manufacturers to resolve the issues as soon as possible and to ensure patients have continuous access to medicines.

We have widely disseminated comprehensive guidance to healthcare professionals about these supply issues, which provide advice on how to manage patients whilst there is disruption to supply. This includes serious shortage protocols to limit prescriptions to one month’s supply to ensure equitable distribution of available supplies and that Creon remains available for those patients who need it. The Department has issued additional management advice to healthcare professionals which directs clinicians to consider the unlicensed imports when licensed stock is unavailable and includes actions for integrated care boards to have local mitigation plans in place and implemented to ensure that no patient is left without PERT.