To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the compliance of the Human Medicines (Amendment) Regulations 2019 with the NHS England Commissioning Framework for Biological Medicines in relation to switching medicines without consulting patients.
14 February 2019
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.