National Program for the Research of Illegal Medicines

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APEC LSIF Second ASIA Anti-Counterfeiting
Medical Products Seminar Building International
Cooperation to Protect Patients March 30th to
April 1st Singapore
Quality of Medicines in Latin AmericaArgentine
National Program for Research of Illegal
Medicines Dr. Maximiliano DERECHO Alternate
Coordinator - Nacional Program for Research of
Illegal MedicinesNATIONAL INSTITUTE OF MEDICINES
A.N.M.A.T. ARGENTINA mderecho_at_anmat.gov.ar
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Introduction

• Counterfeit drugs are a global public health
  problem causing death, disability and injury
  affecting adults and children. No country is free
  of this problem, which plagues developing and
  developed countries alike.
• National Medicines Regulatory Agencies must
  devise pro active strategies to prevent and
  fight it efficiently.

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Research Program
The primary aim of the Program is to counteract
the commerce of counterfeit drugs in order to
guarantee quality, effectiveness and security of
the pharmaceutical products.-
The Program is based on a rigid control of the
legal drugs distribution channels.-
The methodology is based on Visual
and organoleptic inspection of pharmaceutical
products Research of the documents
that support the acquisition or
holding of the products Drugs
sampling along the national distribution chain
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Organization chart
COORDINATOR ALTERNATE COORDINATOR
INSPECTORS STAFF
TECHNICAL SUPPORT STAFF
LEGAL ADVISOR
ADMINISTRATIVE STAFF
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Illegal Drugs
Illegal Drug is a broader concept than
Counterfeit Drug. Illegal Drug includes the
following products

• - Counterfeit drugs
• - Products without authorization from
• the health authority
• - Adulterated pharmaceutical products
• - Smuggled products
• - Stolen drugs
• - Trading of products after expiration
• dates

Instituto Nacional de Medicamentos
-INAME- Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica- ANMAT-
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Counterfeit Medicine
WHO defines a counterfeit medicine as 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
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Main elements to be considerated at seeing
Pharmaceutical products packaging

• Aesthetic features
• Differences in weight/grammage or quality of
  cardboard used
• Differences in the folding of patient information
  leaflets
• Differences in colour and size of tablets/pills
• Differences in the text (missing letters, space
  between lines)
• Changes in the definition or print details of the
  product as a whole
• Use of a different kind of stamps, as to the
  shape or print
• Different colour, brightness or print quality of
  aluminium foils

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Examples of counterfeiting
ORIGINAL
PICTURE
FAKE
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ORIGINAL
ORIGINAL
ORIGINAL
PICTURE
PICTURE
PICTURE
FAKE
FAKE
FAKE
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ORIGINAL
FAKE
PICTURE
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ORIGINAL
FAKE
PICTURES
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FAKE
ORIGINAL
PICTURE
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FAKE
PICTURES
ORIGINAL
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Results in figures1997-2008

• Total number of inspections 30.463

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Detected counterfeit drugs
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Counterfeit pharmaceutical forms
Instituto Nacional de Medicamentos
-INAME- Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica- ANMAT-
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151 laws prohibiting the use and commerce of
counterfeit drugs
Instituto Nacional de Medicamentos
-INAME- Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica- ANMAT-
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Program staff Police Force - Justice

• Legal Proceedings 565
• Counterfeiters dismantled 40

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Proceedings at Illegal Labs
PICTURE
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PICTURE
21
PICTURES
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PICTURE
23
PICTURE
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PICTURE
25
PICTURE
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PICTURES
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Regional Strategies
WORKING GROUP TO COMBAT DRUG COUNTERFEITING.
MISSION To promote, facilitate, and motivate
implementation of proactive strategies for
preventing and fighting drug counterfeiting and
thus contribute to the improvement of health care
in our countries in the Americas.
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Working Group CDC
MEMBER COUNTRIES Argentina - ANMAT Brazil -
ANVISA Canada - Health Canada Colombia
INVIMA Dominican Republic - Secret.
Salud Paraguay - Min. Salud St. Lucia - SPP USA -
FDA
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Working Group CDC
Recommendations of the IV Pan-American
Conference
- To limit the drug marketing to establishments
authorized by the DRA. - To constitute a focal
point network on drug counterfeiting in the
Region establishing a regional network of
communication. - To report on a timely basis to
the WHO database and to the PANDRH Secretariat
the cases of drug counterfeiting that are
detected at the national level.
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Working Group CDC
Recommendations of the IV Pan-American
Conference
- To adopt national standards of good practices
for all the stages of the drugs chain. - To have
mechanism and technologies to trace drugs
effectively in the different stages of the drugs
chain (from production to dispensing), including
the number of batches in the purchase and sale
documents. - To promote reviewing of criminal
legislations, and to include sanctions to crimes
related to drug counterfeiting and other illegal
actions.
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Working Group CDC
Recommendations of the IV Pan-American
Conference
- To adopt rules and measures to prevent the use
of equipment that have been discarded by illegal
manufacturers.- - To adopt measures on wasting of
materials of packaging, label, finished products
and raw materials non-suitable for utilization,
to avoid their used by unauthorized companies and
that do not damage to the environment. - To
strengthen the national programs for drug
surveillance of post-marketing.
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Working Group CDC
Recommendations of the IV Pan-American
Conference
- To preserve the confidentiality in cases of
suspicious drug counterfeit. -To promote the
dissemination and implementation of the
recommendations contained in the WHO Guidelines
for the Development of Measures to Combat Drug
Counterfeiting. - Etcetera.
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Guide to be followed by National Medicines
Regulatory Agencies in case of suspicion on
counterfeit medicines
COUNTERFEIT PRESUMPTION
Legitimacy test at original drug
manufacturer Analytical test at official labs
ORIGINAL
COUNTERFEIT
Measures
Use and commerce prohibition at national level
Report to Justice
Product follow-up in the market
Case diffusion
Instituto Nacional de Medicamentos
-INAME- Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica- ANMAT-
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Guide to be followed by National Medicines
Regulatory Agencies in case of suspicion on
counterfeit medicines
COUNTERFEIT PRESUMPTION
SCHEDULED ACTIONS
Maintaining the state of alert -
Continuity of the Monitoring Program (all over
the distribution chain) - Continuity of
a Contingency Plan for the care of patients
and/or their relatives On-going
furnishing of information to the Judicial
Authority Permanent technical cooperation
Instituto Nacional de Medicamentos
-INAME- Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica- ANMAT-
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Only by means of interdisciplinary cooperation,
could this issue be effectively solved
CUSTOMS
HEALTH CARE AUTHORITIES
EDUCATIONAL INSTITUTIONS
PATIENTS
JUDICIARY
PHARMACEUTICAL INDUSTRY
HEALTH CARE PROFFESIONALS
HEALTH CARE CENTERS
WHOLESALERS
POLICE FORCES
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Thank you!!!
Dr. Maximiliano DERECHO Alternate Coordinator -
Nacional Program for Research of Illegal
MedicinesNATIONAL INSTITUTE OF MEDICINES
A.N.M.A.T. ARGENTINA mderecho_at_anmat.gov.ar