Labeling medicines to counter

counterfeit and fraud

Brian Thornley
Chief Operations Officer

1 Labeling Medicines, Brian Thornley, Aegate Ltd

 New (draft) EU legislation on falsified
medicines – relevant text
 Safety features shall allow wholesale distributors,
pharmacists or persons authorised to supply medicinal
products to the public to identify individual packs and verify
authenticity

 A unique identifier is necessary to identify and verify

authenticity of medicinal products

 A member state may extend the use of the safety feature

for purposes relevant for national policies such as
reimbursement

2 Labeling Medicines, Brian Thornley, Aegate Ltd

Unique Identifiers; a passport number
for each medicinal pack
 1D, 2D or RFID

France Germany Spain? Turkey

Belgium Italy Greece

Labeling Medicines, Brian Thornley, Aegate Ltd

3
 Authentication of the unique identifier
closes the loop

Manufacturer
Pharmacist

Patient

Patient

Every unique number is marked as used when it leaves the

point of dispensing. This way copies are detected.

4 Labeling Medicines, Brian Thornley, Aegate Ltd

 77 duplicates detected across Belgium

These could have

been;

1) Counterfeit

2) Fraudulent

3) Prevented genuine
claims for
reimbursement

Good collaboration with the regulator and the

reimbursement authority is essential

5 Labeling Medicines, Brian Thornley, Aegate Ltd

Unique Identities can link to Health fund
Systems to prevent Fraud
3. Automatic file to
Genuine Product Health fund lists
Not Previously Sold authenticated products
Pro-Active Pharmacy by pharmacy
Response

1. Manufacturer
Supplies serial
Codes to Aegate

Reimbursement
Authority
2. Authentication 4. Authentication
at the point of matches pharmacy
dispensing submission for
payment approval

Pharmacy ID
Prescription Pharmacist Pack Serial ID
Prescription ID

Confidential - For discussion purposes only

 Further Applications for Unique Coding

 Authentication against Fakes

 Reimbursement Fraud

 Prescription Inflation
 Medical Devices
 Treatment Regimes
 Compliance Programmes

7 Labeling Medicines, Brian Thornley, Aegate Ltd

 Unique coding, a opportunity to solve at
least two problems at one time with a
single action

 Thought I'd kill two birds with one stone ...Though I

think I may have only dazed that first fellow!

8 Labeling Medicines, Brian Thornley, Aegate Ltd