The Threat of Counterfeit and Illegally
Imported Medicines
MCM/112514/0058(1)
Overview
Objective
Demonstrate Genentech’s commitment to patient safety by
educating and raising awareness about counterfeit and illegally
imported medicines
Patient safety is Genentech's primary concern
Genentech proactively:
Executive
Summary
• Assesses distribution networks to ensure the integrity of medicines as they
move through the supply chain
• Works closely with suppliers to secure our distribution channels
• Employs systems that track and identify medicines as they move through the
supply chain
• Uses special packaging and printing techniques so illegitimate medicines are
harder to make and easier to detect
• Monitors the Internet and social media channels to identify suspicious
product sources
• Partners with governments to help protect patients from illegitimate medicines
• Provides patients and healthcare professionals with information to help
ensure they can safely access our medicines
2
Patient Safety Is Genentech’s Primary Concern

Genentech is committed to patient safety, to
protecting the integrity of our medicines as they
move through the supply chain, and to ensuring
patients and healthcare professionals are able
to access our medicines when they need them

Medicines that are counterfeit, adulterated,
diverted from approved supply chains, illegally
imported, or stolen pose a significant risk to the
safety of patients. Genentech employs several
strategies to combat these global threats to
public health

We are committed to giving patients and
healthcare professionals the information they
need to safely access our medicines. It is vital
that we all work together to recognize and avoid
illegitimate medicines
3
The Threat of Counterfeit and Illegally Imported
Medicines Is Increasing
It’s nearly impossible to truly quantify the magnitude of the
problem due to the nature of counterfeiting activity
Pharmaceutical Security Institute
(PSI) reported a 139% increase in
counterfeit metabolics in 2013
(compared to 2012)2
48%
50%
40%
27%
30%
29%
22%
20%
10%
Metabolism

The rate of counterfeit injectable
incidents increased 23.4% in the
last year2
60%
Anti-Infective

70%
Respiratory
• This represents a 300% increase in
sales since 20001
Therapeutic Categories Counterfeit Incidents
Percentage Change CY 20132
80%
76%
Hormones
The World Health Organization
(WHO) estimates that counterfeit
medicines constitute a $431 billion
market1:
CNS

0%
Sources: 1. Garrett L. Ensuring the safety and integrity of the world’s drug, vaccine, and medicines supply. Council on Foreign Relations Web Site.
http://www.cfr.org/pharmaceuticals-and-vaccines/ensuring-safety-integrity-worlds-drug-vaccine-medicines-supply/p28256. Accessed January 15, 2015.
2. Pharmaceutical Security Institute. PSI 2013 Situation Report. Vienna, VA: The Pharmaceutical Security Institute, Inc; 2014.
4
Counterfeit or Illegally Imported Medicines Put
Patients’ Safety at Risk
 The safety and efficacy of counterfeit, adulterated, diverted, illegally
imported, and stolen medicines cannot be ensured
 Analysis of seized counterfeit medicines has revealed:
• That they may contain too much or too little of the active ingredients, or
none at all. They may even contain harmful chemicals
• Even authentic medicines that are removed from the legitimate supply
chain may harm patients
– These diverted, illegally imported, and (in some cases) stolen
medicines may not be stored or handled properly
– They could be contaminated or damaged
The safety and effectiveness of counterfeit medicines cannot be ensured
5
Impact of Counterfeit or Illegally Imported
Medications Goes Beyond Patient Safety
Counterfeit case study linked to Avastin (bevacizumab) Solution
for Intravenous Infusion uncovered risks related to unauthorized
distribution and created alarm.




Following discovery of counterfeit Avastin in
2012, FDA initially sent letters to 19
medical practices about counterfeit Avastin
and other unapproved products
Since then, over 1,100 practices have
received warning letters about purchasing
unapproved products, and these letters
have been posted on the FDA website
This counterfeit Avastin incident involved
distribution chain companies in 5 countries
and 880 physicians in the U.S.
More than 18 high-profile arrests and
convictions linked to the Avastin
investigation included treating physicians
and distributors
6
Genentech Is Raising Market Awareness: Direct
Mail to Oncology Practices
•
Date: September 2013
•
Target Audience: Oncology Practices and Hospitals
− Physicians
− Nurses
− Practice/Office Manager
•
Key Messages:
− Importance of purchasing from authorized
distributors
− Genentech’s list of authorized distributors:
http://www.genentech-access.com/hcp/learn-aboutour-services/our-services/product-distribution
− Genentech products approved for use in the U.S.:
www.gene.com/medical-professionals/medicines
− To learn more about Genentech’s response to
counterfeit and illegal importation:
http://www.gene.com/medicalprofessionals/product-security
7
Genentech Works With Partners to Help Protect
Patient Safety
Roche and Genentech employ several anti-counterfeit strategies to help ensure the integrity of our medicines as
they move through the supply chain and protect patients from illegitimate medicines:
 We work closely with suppliers to secure our distribution channels and we regularly assess our distribution
networks to ensure each of our medicines is distributed through the most appropriate channel
 We have built systems that allow our medicines to be identified and tracked as they move through the supply
chain
 We use special packaging and printing techniques so illegitimate medicines are harder to make and easier to
detect
 We partner with governments to help protect patients from illegitimate medicines
Controlled Distribution
Models
Counterfeit Prevention
Program
Anti-counterfeit
Packaging
Partnerships With
Government Entities
Drug Quality and
Security Act
8
Genentech Works With Partners to Help Protect
Patient Safety
Roche and Genentech employ several anti-counterfeit strategies to help ensure the integrity of our medicines as
they move through the supply chain and protect patients from illegitimate medicines:
 We work closely with suppliers to secure our distribution channels and we regularly assess our distribution
networks to ensure each of our medicines is distributed through the most appropriate channel
 We have built systems that allow our medicines to be identified and tracked as they move through the supply
chain
 We use special packaging and printing techniques so illegitimate medicines are harder to make and easier to
detect
 We partner with governments to help protect patients from illegitimate medicines
Specialty distribution models
provide greater control over
product integrity, with reduced
number of intermediaries and
shipping points
The Counterfeit Prevention
Program is a cross-functional
program chartered to develop and
implement U.S. counterfeit
prevention strategies in
coordination with the Global Roche
Anti-Counterfeiting Commission
We utilize several different
safeguard approaches on products
we manufacture to help ensure
authenticity
Where possible, we support local,
state, and federal government
efforts aimed at combating
counterfeit and illegally imported
medicines
Tracing history, serialization, and
verification – adherence to Drug
Quality and Security Act – Article II
9
Drug Quality and Security Act (DQSA) — Article II
Transaction
Data
 Effective January 1, 2015, the law requires pharmaceutical manufacturers and
distributors to provide transaction histories, transaction information, and transaction
statements (TH/TI/TS) to their customers every time a unit of commercial product is
sold in the United States
Verification
 Effective January 1, 2015, all manufacturers, repackagers, wholesalers, and
dispensers must promptly alert law enforcement should they identify any product as
counterfeit, diverted, stolen, adulterated, subject to a fraudulent transaction, or
otherwise unfit for distribution
GTIN
S/N
EXP
LOT
00350242040624
00000000008763
JUN 2016
TEST01
Unit
Case
Label with serial number
Pallet
Serialization
 Effective November 27, 2017, all manufacturers are required to have unique serial
numbers on all commercial units and homogeneous cases of their drug products
sold in the United States
10
Genentech Recommendations to Help Protect
Patients

Be wary of new or unfamiliar distributors that offer deep discounts:
• Familiarize yourself with the medications you prescribe or dispense to patients,
paying specific attention to the presence of altered or unsealed containers or
changes in the packaging of the medicine
• Products where the labeling is not in English and those that lack a National Drug
Code (NDC) number are likely to be counterfeits or illegal imports

Educate prescriber networks that even authentic medicines that are approved
for use in other countries may harm patients
• These illegally imported medicines may not have been stored or handled properly.
They could be contaminated or damaged

Ensure that medicines are purchased from legitimate distributors that are
licensed to operate within the United States

Bring any differences in the physical appearance or taste of the medicine, or
unexpected side effects experienced by the patient to the attention of the FDA
(1-800-FDA-1088) and Genentech (1-888-835-2555)
Contact your Genentech Account Manager for more ways to get involved
11
In Summary
 Counterfeit or illegally distributed medicines put patients’ safety
at risk
 Patient safety is Genentech’s primary concern and we are taking
steps to protect patient safety by:
• Continually reevaluating our business controls to optimize the security of
its supply chain
• Working closely with suppliers to secure our distribution channels
• Exploring new technologies to help prevent and detect counterfeits
• Working with the industry to promote the development of a national
pedigree law
Genentech takes seriously its responsibility to provide information as needed
to health authorities or law enforcement agencies to address
reports of counterfeit or illegally imported medicines
12