To ask the Secretary of State for Health and Social Care, with reference to the proposed amendments to the Human Medicines Regulation 2012, what treatment areas will be excluded from the serious shortage protocol for reasons of patient safety; and if he will publish a list of medicines and formulations that will be excluded as a result.
A Serious Shortage Protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.
As the explanatory memorandum of the amending Statutory Instrument acknowledges, 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.