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NHS: Drugs

Question for Department of Health and Social Care

UIN 219498, tabled on 11 February 2019

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.

Answered on

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.

Answered by

Department of Health and Social Care
Named day
Named day questions only occur in the House of Commons. The MP tabling the question specifies the date on which they should receive an answer. MPs may not table more than five named day questions on a single day.