Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if she will make an assessment of the adequacy of the availability of enzyme replacement therapy.

We are aware of the supply issues with the three enzyme replacement therapies, Creon 10,000 gastro-resistant capsules, Creon 25,000 gastro-resistant capsules, and Nutrizym 22 capsules. These are due to manufacturing and active pharmaceutical ingredient constraints. The Department will be issuing updated guidance to healthcare professionals regarding treatment of patients while there is a disruption to the supply of these pancreatic enzyme replacement therapies. We are having regular conversations with the suppliers of these products to help drive the resolution of these issues as quickly as possible, for example by expediting orders and increasing forecasts. We are also working with specialist importers to source unlicensed imports from abroad.

Whilst we can’t always prevent supply issues, we have a range of well-established tools and processes to mitigate risks to patients. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols, and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals, so they can advise and support their patients.