Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Explanatory Memorandum to The Human Medicines (Amendment) Regulations 2019, 7.12, whether in the event of a Serious Shortage Protocol being issued for immunosuppressant medicines patients would always be referred back to the prescriber for any decision on their treatment before any therapeutic or generic alternative is supplied.

While Serious Shortage Protocols (SSP) in England have the scope to cover all medicines and appliances that are on a National Health Service prescription in primary care, including immunosuppressant medicines, it is clear that an SSP for therapeutic or generic equivalents will not necessarily be suitable for all medicines and patients. For example, where medicines need to be prescribed by brand for clinical reasons, which may be the case for certain immunosuppressant medicines. In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any alternative is supplied.

Any protocol would however only be introduced if clinicians with expertise in the relevant area think it is appropriate. So, if an SSP for an immunosuppressant medicine was under consideration, this would be agreed with, for example, transplant specialists or other relevant clinicians. Pharmacists will have to use their professional judgment as to whether supplying against the protocol rather than the prescription is appropriate or the patient should be referred to their prescriber.