Drugs: Counterfeit Manufacturing

No assessment of the impact of the disapplication of the EU Falsified Medicines Directive (EU FMD) on the United Kingdom’s medicine supply chain has been made by the Department. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is not aware of any falsified medicines reaching patients through the legal supply chain in at least the last five years.

The MHRA leads work to combat falsified medicines and protect patient safety, including through the application of the Human Medicines Regulations 2012 to online and retail sales. The MHRA uses several different approaches to support its work to combat falsified medicines entering the UK supply chain, including by leveraging emerging technology, for instance:

• Its FakeMeds campaign guides the public on how to buy medicines online from safe and legitimate sources;
• suspected side effects or falsified medicines can be reported through the MHRA’s Yellow Card scheme;
• it is exploring the use of artificial intelligence to proactively identify illicit internet domains for enforcement action;
• it is working with Ofcom to use the new preventative powers provided by the Online Safety Act for regulating online platforms;
• it is developing an online service enabling users to check whether a website has been classified as ‘Not Recommended’; and
• it is developing a new web-based reporting tool to allow users to report suspicious online sellers directly to its Criminal Enforcement Unit.

Any additional initiatives to use emerging technologies, such as smartphone verification scanning, would require careful consideration of the evidence of the reduction of the risk to patients, as well as investment needed for infrastructure, and further regulatory changes for manufacturers and wholesalers. There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU FMD with ‘safety features’ and verification in the UK. However, the powers allow us to go beyond the EU 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, medicine supply, preventing diversion, supporting patient access to medicines, and countering fraud in primary care. However, regulations would be needed to set out the detail of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system.