Making a Killing
The Deadly Implications of Substandard
and Counterfeit Drugs
What is a counterfeit drug?

WHO’s definition:
“A counterfeit drug is a drug that has been
deliberately and fraudulently mislabeled with
respect to identity and/or source. Counterfeiting can
apply to both branded and generic products
and…may include products with the correct
ingredients or with the wrong ingredients, without
active ingredients, with insufficient active ingredients
or with fake packaging.”
Counterfeit drugs
1.
2.
3.
4.
Substandard drugs : the amount of
active substance is lower than as stated
Fake drugs: contain no active
substance
Falsified drugs: active substance is
changed/replaced with other substance
“Cheating”: traditional (herbal)
medicine contains chemical/synthetic
active substance but not declared
Counterfeit and Substandard drugs
COUNTERFEIT DRUGS
Willfully
mislabeled as to
identity or
source, but not
always a
trademark
violation
SUBSTANDARD DRUGS
Well-made drugs that
are old or poorly
stored, badly-made
drugs
Counterfeit drugs
The most counterfeited drugs in the
developed countries (e.g. USA): high
volume and expensive drugs, like
antiretroviral, anti impotency, and
psychiatric medicines.
 The most counterfeited drugs in
developing countries: high volume but
not necessarily expensive, such as:
paracetamol, anti malarial drugs,
vaccines.

Medicines that could kill millions
(New Scientist, 08 September 2005)
In 1995 in Niger: 60.000 people
inoculated with fake meningitis vaccine
 In 2001 in China: 192.000 patients died
after taking counterfeit drugs
 In Africa: active substances of ART drugs
are replaced with tranquilizers
 In Mekong Region: 40% of artesunate
(anti malarial drug) are fake.

Indonesia
Sales of counterfeit drugs: Rp.21 billion/year
(Parulian Simandjuntak)
 Chemical substance is added to traditional
medicines sold freely  hazardous to health
 Chemically active substance sold as
“traditional medicine” or “food supplements”
through MLM (BPOM/Depkes are not aware?)
 “Cheating” or “misleading information”, like
“tolak angin” and “obat panas dalam”

The professionals
Many doctors are not aware of the
existence of counterfeit drugs
 Many doctors and pharmacists cannot
distinguish the counterfeit drugs from
the original
 No information, education and training
on this problem

Why is there an increase in poor
quality drugs?

Low marginal cost, high demand and high marginal
returns
 Historically weak rules preventing fakes; still poor
enforcement of new rules
 low penalties for producers, traffickers and
packagers, which is encourages the fake drug trade
 Corruption lowers capture rates in many places

Enabled by:


Complex and opaque supply chains, with many parties
ignorant of good practice
Confusion over definitions (incorrect drug seizures - EU,
anti-counterfeit laws conflating patents with trademarks)
A Silver Lining
New Definitions

Authorized/Registered Products
Good standard
Substandard

Not authorized/non-registered products
Good standard
Good standard and labeling/trademark violation
Substandard
Non-counterfeit substandard drugs –
some developing country estimates
COUNTERFEIT DRUGS
Willfully mislabeled as
to identity or source,
often, but not always,
a trademark violation
SUBSTANDARD DRUGS
Non-counterfeit
India – 95%
Cambodia - 25%
China – 65%
Faking an Indian Brand
Fake on Right
Lipitor® (atorvastatin calcium)
Which one is the counterfeit Lipitor®?
Source: Pfizer Inc.
Lipitor® (atorvastatin calcium)
Which one is the counterfeit Lipitor®?
FAKE
AUTHENTIC
Source: Pfizer Inc.
Celebrex® (celecoxib)
Which one is the fake?
COUNTERFEIT
AUTHENTIC
Source: Pfizer Inc.
Counterfeit Operations
Counterfeit Gabantin
Drugs purchased
over the Internet by
an American patient
who was told that
the products were
manufactured in the
United States and
were being sold
from Canada. The
drugs he actually
received are fake
“knockoffs” from
India.
Counterfeit Zantac
Manufactured in Taiwan,
discovered in United
Kingdom.
Excellent packaging of
counterfeit, even includes
counterfeit package insert.
Source: Pharmaceutical Research Manufacturers Association
Counterfeit Ponstan
Ponstan is an anti-inflammatory product. This counterfeit was found in
Columbia. First is the yellow powder; it consist of boric acid, floor wax,
yellow highway paint. Pressed into tablets and placed in foil packs with
labeling.
Source: Pharmaceutical Manufacturer Research Association
Authentic Ortho Evra Contraceptive
Patch and packaging
Property of Marv Shepherd,
University of Texas
Counterfeit Patch—no
active ingredient
Viagra® (sildenafil)
Which one is the fake
drug?
Viagra® (sildenafil)
Which one is the fake
drug?
AUTHENTIC
FAKE
Manufacturing Facility for Counterfeit Panadol
This facility
depicts the
conditions in
which many
counterfeits are
manufactured.
This counterfeit
lab was found
in South East
Asia.
Source: Pharmaceutical Research Manufacturers Association
Counterfeit Operations
Counterfeit Operations
Counterfeit Operations
Counterfeit Operations
Why is counterfeiting a problem?

Public health threat:




Direct: Fake drugs containing harmful ingredients (e.g. heavy
metals)
Indirect: Drugs with inadequate or wrong active ingredients
have no curative power (e.g. many malaria deaths)
Wider Impacts: Drugs with only some of the correct
ingredients can cause a patient to develop resistance to that
particular drug, making it harder for the patient (and potentially
the population as a whole) to be treated with effective
medicines later on (drugs for TB, HIV, malaria badly affected).
Intellectual property/brand integrity threat

Threatens long-term innovation and development
The Global Face of Bad Medicine
COUNTRY/
REGION
WHO/IMPAC
T ESTIMATE
COUNTRY/
REGION
WHO/IMPACT
ESTIMATE
United States
<1%
Russia
10%
Europe
<1%
CIS
20%
United Kingdom
<1%
China
8%
Indonesia
25%
India
10-20%
Nigeria
16%
Kenya
30%
Lebanon
35%
Cambodia
13%
Extent of Counterfeit Drugs and Major Sources



It has been estimated
by the WHO that
counterfeit drugs
comprise 8 percent of
the world market.
For some countries
(African, Latin)
counterfeits comprise
40 to 50 percent of the
market.
Estimated to be $20 to
over a $40 billion
market. (WHO)

Sources of Counterfeit
Drugs

India—it is estimated at
15 to 20% drugs are
fake. (Script, April 16,
2003)







China
Brazil (40% to 50% fake)
Mexico (25% fake)
Pakistan
Belize
Chile
Southeast Asia
Countries (30 to 50%)
What can be done to combat
counterfeiting?






Legislation banning counterfeit products,
approve budget to enforce such legislation
Increase penalties for counterfeiters
Increase enforcement efforts (including technical
monitoring of quality at ports, randomly within
country)
Improve education of intermediaries in how to
spot counterfeit products
Reward whistleblowers
Product tracking (simplify supply chains?)
WHO’s work in combating counterfeit
medicines:
Three strategies
1. Providing tools, international norms, standards and
guidelines to assist that medicines circulating in national
and international commerce are safe, efficacious and of
good quality
2. Providing support to Member States to build national
regulatory capacity
3. Developing global activities to combat counterfeit
medicines, in collaboration with all relevant stakeholders
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Milestones in WHO's work in anti-counterfeiting (1)
1988:
Resolution WHA 41.16 requests WHO to initiate programmes for prevention
and detection of exportation, importation and smuggling of counterfeit
medicines
1992:
First international meeting on counterfeit drugs organized by WHO, CIOMS
and IFPMA gives first definition of 'counterfeit drug'
 called all parties involved in manufacturing and distribution as well
consumers to collaborate with governmental institutions in combating
counterfeit drugs
 called all parties involved in manufacturing and distribution as well
consumers to collaborate with governmental institutions in combating
counterfeit drugs
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Milestones in WHO's work in anti-counterfeiting (2)
1994:
Resolution WHA 47.13 requesting WHO to assist Member States in their
efforts aimed at combating counterfeit drugs.
1996:
WHO Project on Counterfeit Drugs
1999:
Guidelines for the Development of Measures to Combat Counterfeit
Drugs, guidance that is far from being achieved in the majority of WHO
Member States.
2000-2005: WHO, IFPMA, EGA, PSF Working group on counterfeits
2001: WHA Technical Briefing
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Milestones in WHO's work in anti-counterfeiting (3)
1994-2004:
Several ICDRA* requests to WHO to assist Member States to adopt
measures to combat counterfeit medicines
2004:
ICDRA requests WHO to work towards international convention on CF
medicines
2005-2006:
No consensus among Member States on international convention on CF
medicines
February – July 2006:
Rome conference recommends establishment of an international taskforce.
Terms of Reference and name (IMPACT) endorsed at second meeting in
Rome
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Milestones in WHO's work in anti-counterfeiting (4)
September 2006:
Circular Letter announcing the establishment of IMPACT to Member States
November 2006:
First IMPACT General Meeting, Bonn - nominating IMPACT Chair and ViceChairs, Chairs of Working Groups, and establishment of a Work Plan for 2007
December 2007:
Second IMPACT General Meeting, Lisbon – endorsement of "Principles and
Elements for National Legislation"
May 2008:
Discussion of WHO report and draft resolution in WHA; much disagreement
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December 2008:
Third IMPACT General Meeting, Hammamet/Tunisia; "IMPACT definition"
approved
Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Milestones in WHO's work in anti-counterfeiting (5)
19-27 January 2009
WHO Executive Board requests WHO to prepare two background
documents for WHA in May 2009: (1) WHO's activities in substandard
and counterfeit medicines; (2) IMPACT and potential conflict of interest
18-23 May 2009
World Health Assembly - discussion postponed to WHA 2010
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
IMPACT conceptual approach
1) IMPACT is a voluntary coalition of partners, with the purpose of coordinating
international activities aimed at combating counterfeit medical products
2) IMPACT partners reflect the fact that combating counterfeiting of medical
products cannot be successfully achieved by the health sector alone but requires
a coordinated effort and effective collaboration among health sector,
enforcement, border control, justice (all at different administrative levels), as well
as health professionals, manufacturers, importers, distributors, media, and
patients/consumers
3) IMPACT is led by WHO (Chair, Secretariat) with a focus on the public health
implications of counterfeiting rather than on IPR-related aspects
4) IMPACT outputs include recommendations, policy advice and training
materials that reflect consensus reached among IMPACT partners
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
All 193 WHO Member States and major international
partners are members of IMPACT
European Commission
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
How does IMPACT work?
Secretariat:
WHO (in the Department of Essential Medicines and Pharmaceutical
Policies, WHO, Geneva)
Executive Secretary a.i.: Dr Sabine Kopp
Five IMPACT working groups:
Technical areas where weaknesses were identified and action is required at
national and international level:
1) legislative and regulatory infrastructure
2) regulatory implementation
3) enforcement
4) technology
5) communication
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Political issues arising during the past 12
months
47

Concerns by many developing countries that the fight against
counterfeit medicines may have a negative impact on free trade in
generic products

Use by some countries and companies of the counterfeit argument
for limiting free trade / competition / parallel trade

Use of the term "counterfeit medicinal product" in patent disputes;
suggesting that the term counterfeit medicines should exclusively
be used for IPR disputes and not for public health

Concerns from some parties that certain technical measures would
be too costly, e.g. for OTC and generic medicines

Major divisions in the WHO / EB and WHA, especially between
USA/EU/Africa and L.America (Brazil)/Asia (India).
Essential Medicines and Pharmaceutical Policies, WHO, Geneva
Future … until WHA 2010 and beyond
WHO:

New programme in WHO/EMP: Anti-Counterfeit Medicines (ACM)

Fund-raising and staffing for ACM and IMPACT related activities

Close collaboration of ACM with regulatory and quality assurance
programmes and WHO Expert Committee (IMPACT documents on
distribution chain and model legislative text)

Communication with Member States to prepare for WHA 2010
IMPACT:

Continuation of WHO involvement in IMPACT (chair, secretariat)

Communication with IMPACT partners and working groups, IMPACT
web site clearly separated from WHO/EMP

Regional and 4th General IMPACT meetings organized

Enforcement activities with Interpol and national authorities
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva
www.who.int/medicines
Thank you!
The Essential
Medicines family
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Essential Medicines and Pharmaceutical Policies, WHO, Geneva