Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what plans he has to support pharmaceutical staff in (a) making a decision to ration medicines to avoid extreme shortages and (b) changing prescriptions as a result of shortages without consulting a GP in the event that the UK leaves the EU without a deal.

No assessment has been made. However, the explanatory memorandum of the amending Statutory Instrument acknowledges that protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, such protocols would not be suitable for medicines that need to be prescribed by brand for clinical reasons, such as biological medicines. In these cases, patients would always be referred to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.

The Serious Shortage Protocol provisions in the Human Medicines (Amendment) Regulations 2019 enable Ministers, in exceptional circumstances, to issue a protocol that enables retail pharmacies to dispense in line with a protocol for a specific prescription only medicine rather than against a prescription, without going back to the prescriber.

Any protocol would need to set out what alternative quantity, pharmaceutical form, strength, therapeutic equivalent or generic equivalent can be supplied in what circumstances.