How to secure product brand integrity with integrated protection strategies

A presentation from Dr. Edgar Mentrup der Merz Group Services GmbH

- Background information
- Technologies to prevent/detect counterfeits
- Integrating approaches, cost effective
- How do others manage?

Definition of WHO:
“a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source.
 Counterfeiting can apply to both branded and generic products and counterfeit products may include products

• with the correct ingredients or
• with the wrong ingredients,
• without active ingredients,
• with insufficient active ingredients or
• with fake packaging”.

Actual situation (US)
2008 seizures totaled more than $272.7 million in counterfeit and pirated goods, an increase of 38 percent over the previous year

Product-recalls in UK due to counterfeits

Lipitor Tablets (Pfizer) 2005
– Tablets contain lovastatin as opposed to Atorvastatin
– Recall of 120,000 packs - 73 packs of counterfeit drug seized
Casodex Tablets 50 mg
– Bicalutamide, Astra Zeneca, June 2007:
– Parallel import. Contains about 75% of the active ingredient
Plavix Tablets 75 mg
– Clopidogrel, Sanofi-Aventis & Bristol Myers Squibb, May 2007:
– Parallel import. Contains 70 - 80% of the active ingredient

Technology – requirements

- Economics (depending on product, price, margin, ..)
- Authentication (Quality,speed)
 • Patient/consumer
 • Pharmacists / doctors (professionals)
 • Company associates (selected)
 • Officials (police, customs, investigators)
- No or minimal impact on productivity (line speed,..)
- Risk of imitation/Quality of protection (duration before replication)
- Integration into company workflow (order, handling, ..)
- Flexibility / options for changes (costs & communication !)
- Forensic validation of marker fingerprints for legal action

Protection measures - differentiation

Covert / high level

• Only visible to trained staff
• Most often special equipment required
• Very difficult/impossible to replicate

Cover / low level

• Visible to trained staff
• No special equipment required
• (only e.g. UV light)

Overt

• Visible to everybody (e.g. color)
• No special equipment required
• Communication to customer required
• Risc for replication requires regular updating

 

Identifying the product itself

Raw materials– API to identify the source of material and understand chain
  e.g. specific pattern of related substances
– Addition of markers/tracers

Printing / Embossing– Nano-technologies
– 2D Codes
– On-tablet laser inscription technique, DataLase Pharmamark(TM).

Film coatings includes an additive that induces a color change in
the film coating precisely at locations on the tablet surface exposed
to a low-power CO2 laser. Identification control of every single
tablet.

Special coating of solid dose forms ...

To view all details of this presentation, download the PDF now: Global Pharma Authentication and Counterfeiting.

(c) Dr. Edgar Mentrup, Merz Group Services GmbH, 2009

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