Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they are developing to create a barcoded stock management system for medicines, akin to the EU's falsified medicines directive.

The European Union’s Falsified Medicines Directive’s (FMD) primary purpose was to help prevent falsified medicines from entering the legal supply chain through the introduction of safety features on the packaging and verification at certain points of the supply chain to confirm authenticity. The monitoring and management of shortages was not part of its original legal framework.

There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU’s FMD’s ‘safety features’ and verification in the United Kingdom. However, the powers allow us to go beyond the FMD and use derived data from any system for other health related purposes. For example, to support the recall of medicines, to support patient care, research, policy development, and medicine supply, to prevent diversion and support patient access to medicines, and to counter fraud in primary care. Regulations would be needed to set out the details of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system. Any consultation would be published in the usual way on the GOV.UK website.