Factsheet: falsified medicines
Updated 25 January 2021
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Top lines
The UK has a low prevalence of falsified medicines and there are robust strategies and operational protocols in place to protect patients. However, we want to continue to protect patients from the real and present threat posed by falsified medicinal products.
We remain committed to tackling the public health threat they pose and ensuring that the UK continues to protect patients and secure access to the best and most innovative medicines.
Without the powers provided by the bill, we would be unable to put in place a bespoke falsified medicines system. In the context of the global trend towards securing the legitimate supply chain, we will be evaluating all options to ensure that the UK remains protected against the threat of falsified medicines.
What the bill does
It provides powers that enable us to protect patients from the threat posed by falsified medicines.
The powers enable us to introduce a scheme to safeguard the supply chain against falsified medicines.
It has the flexibility to let us deliver an innovative model that protects safe access to medicines whilst delivering substantial UK and NHS specific benefits.
Why we are pursuing these particular powers
As the UK has exited the EU, the ‘safety features’ element (serialisation) of the EU Falsified Medicines Directive (FMD) ceased to have effect in Great Britain from 31 December 2020.
The EU FMD seeks to prevent falsified medicines entering supply chains, including through the use of safety features to be included on packs of prescription medicines.
We need to be able to establish a national scheme to continue to deter falsified medicines.
What a falsified medicine is
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. It is any medicine that is different to what it is described as. This can include a false representation of its identity, source or history.
The powers in this bill can be used to protect patients from the public health threat of falsified medicines. This is distinct from addressing medicines that are counterfeited, which involves intellectual property disputes.
What a national falsified medicines scheme offers
The ability to check a medicine’s authenticity.
Based on our learning from the EU FMD system, the ability to use data to thoroughly investigate instances of falsified medicines.
Guided by our engagement with stakeholders, it could include additional uses of data for other purposes to do with human medicines, so long as they are in the public interest.
Our plans for consultation
We are committed to public consultation on the need and details of any national scheme as well as a specific consultation on the use of data collected as part of any scheme.
We expect to have a staged approach to engagement and consultation across the supply chain, with an initial aim of issuing a public consultation within 12 months of Royal Assent, subject to other priorities around medicines regulation.