# Presentation: 530367

## Security Systems Division

***Securing the Pharmaceutical ***
***Supply Chain***

***Dr. Andrew D. Dubner***
***February 9, 2006***

## Tracking Requires Compliance

- Compliance

- Incentive

- What is the benefit?
- Security and

## Authentic packaging – what indications are there that the packaging and associated labeling are genuine?Package integrity – what indications are there that the packaging and associated labeling have not been tampered?Supply Chain history – what information is available to determine that the product has been handled by trusted supply chain partners? 

**Is:**

**Should be:**

**Authentic Package**

**Package Integrity**

**Supply Chain**

**Contents**

- A

- A

- A

- Ø

**Authentic packaging** – what indications are there that the packaging and associated labeling are genuine?**Package integrity** – what indications are there that the packaging and associated labeling have not been tampered?**Supply Chain history** – what information is available to determine that the product has been handled by trusted supply chain partners?

- Optimized Security Solution

## Securing the Pharmaceutical Supply Chain

**Problem:**
**Counterfeit drugs pose an increasing and serious threat to patient safety.**
**Hypothesis:**
**Item-level authentication that bridges the ends of the supply chain will have an immediate impact in addressing the problem.**
**Focus:**
**How do we best increase confidence, across the supply chain, that genuine product is dispensed to patients?**
**AND provide compelling business results for all constituents?**

## Authenticated RFID

**A platform to:**
**Authenticate**
**Identify**
**Secure**
**Track**
**Start with basic capability **
**Activate features as infrastructure expands**

## Authentication

**Reader**

**      ****PKI      **

- ISO
- Standard

- With OR without
- Network

- Unique encrypted
- Digital Signature

**Tag has factory locked unique serial number and Labeler Code ID**
**Each product manufacturer has a unique encryption key**
**Digital signature provides a manufacturer specific security mark**
**Reader automatically authenticates multiple manufacturer’s products**

## ePedigree (Identify and Track)

**RFID Tag**

**Reader**

**Network**

- Event Marker
- (time stamp)

- Event Digital Signature
- Other info (user defined)

**Item-level identification**
**Reader provides authentication to network**
**ePedigree is realized as number of readers installed increases**
**Pedigree generated through network / software**

## Authenticated RFID Platform Benefits

**Authentication at the most relevant points in the supply chain – manufacturer and dispenser**
**Enables ePedigree – consistent with EPCglobal standardization**
**Compelling Business Results through operational benefits **
**Supply chain data**
**RFID tagged products in supply chain**
**Establishes a scalable platform for additional security elements to elevate confidence in:**
**Authentic packaging**
**Package Integrity**
**Trusted Trading Partners**** **

## “Bookend Authentication” Pilot

_**Security Solution**_** for one of the products on the National Specified List of Susceptible Products***
**Tagging at manufacturer – establish authenticity**
**Validate authenticity at dispensers**
**Both manufacturer and dispenser have identified business justification for implementation - incentives for compliance**
**Flexibility and simplicity of platform approach is an enabler**

- * National Association of Boards of Pharmacy (NABP)

## www.3M.com/security