For many years, pharmaceutical crime has often been presented in terms of a relatively simple distinction: legitimate medicines are supplied through regulated channels, while falsified and illicit medicines circulate outside them.
That distinction is becoming increasingly difficult to sustain.
In February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning concerning falsified Mounjaro (tirzepatide) 15mg Kwik Pens. Five affected pens were identified after being supplied through a UK online pharmacy.[1]
Testing confirmed that the recovered falsified pens contained tirzepatide. However, their manufacturing conditions and sterility could not be assured, and all had faulty mechanisms.
The presence of the expected active ingredient did not make the products legitimate or safe.
The incident highlights a broader challenge facing the pharmaceutical sector: falsified medicine is not always confined to clearly illicit markets. This vulnerability may not be immediately visible to manufacturers, distributors, healthcare providers, or regulators.
When legitimate and illicit markets intersect
A falsified medicine does not necessarily remain within an obviously criminal supply chain.
Criminal actors can exploit legitimate businesses, suppliers, intermediaries and distribution arrangements. Genuine product information may also be misused: the falsified 15mg pens reportedly carried a batch number belonging to genuine Mounjaro 7.5mg pens.
It also raises an important question:
If a falsified medicine reaches an apparently legitimate channel, where should it have been detected?
Effective prevention requires organisations to understand how products are sourced, who supplies them, how they move through the supply chain, and what indicators might suggest something is wrong.
These are no longer simply procurement, quality or regulatory questions. They are also questions about the risk of pharmaceutical crime.
The right ingredient does not mean the right medicine
The case also challenges a common perception about falsified medicines.
“Fake” does not necessarily mean a product contains no active pharmaceutical ingredient. A falsified product may contain the expected substance, while still presenting significant risks due to unknown provenance, manufacture, strength, quality, storage, or sterility.
That distinction matters.
It moves the discussion beyond identifying obviously fraudulent products towards understanding the integrity of the pathway through which medicines reach patients.
Are we connecting the warning signs?
Organisations may have established policies, approved suppliers, and procurement controls, yet still face criminal exploitation.
- An unusual supplier
- Unexpected availability of a scarce medicine
- Pricing anomalies
- Packaging discrepancies
- Product faults
- Patient complaints
- Unusual purchasing patterns
Individually, these may appear insignificant. Collectively, they may represent intelligence.
Once a falsified medicine is identified, the questions should therefore extend beyond the product itself.
Where did it originate? How did it enter the supply chain? Who facilitated its movement? Was it an isolated incident or part of a wider pattern? And what vulnerability allowed it to happen?
No single organisational necessarily sees that complete picture.
Organisations should therefore consider three questions:
- Do we understand where our pharmaceutical supply chain is most vulnerable to criminal exploitation?
- Can we recognise and connect weak signals before they become significant incidents?
- When an illicit product is discovered, can we investigate beyond the product to understand the network and vulnerability behind it?
The challenge is no longer simply about keeping falsified medicines from infiltrating legitimate supply chains. It is recognising how criminal activity can exploit the connections between legitimate and illicit markets.
Pharmaceutical crime has changed. The question is whether our response has kept pace.
[1] https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens
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Read More →For many years, pharmaceutical crime has often been presented in terms of a relatively simple distinction: legitimate medicines are supplied through regulated channels, while falsified and illicit medicines circulate outside [...]
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