Rx%20Roulette:%20Counterfeit%20Pharmaceuticals%20in%20Developing%20Nations

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Rx RouletteCounterfeit Pharmaceuticals in
Developing Nations
LeBow College of BusinessDrexel University

• Dr. Kristina M. Lybecker
• December 6, 2003

• Prepared for the conference, Markets for
  Pharmaceuticals and the Health of
• Developing Nations, Toulouse, France, December
  5-6, 2003.

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• As early as the fourth century BC people were
  warned about the dangers of adulterated
  medicines, and despite all the advances made over
  the years this concern has not disappeared.
• World Health Organization.
•  
• In the next ten years, spurious drugs will be
  the single biggest problem in public health.
• Ranjit Roychoudhury, President of the Delhi
  Society for the Promotion of the Use of
  Rational Drugs, as quoted in The Lancet.
•  
• Some health officials in Africa have stated
  that counterfeit medicines are a greater public
  health threat than AIDS or malaria.
• Harvey Bale, President of the International
  Federation of Pharmaceutical Manufacturers
  Associations (IFPMA), as quoted in The Lancet.

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Introduction

• Challenge to Public Health
• Characteristics of the Problem
• Facilitating Factors
• Available Strategies to Combat Counterfeiting
• Conclusions

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Counterfeiting and Public Health

• Mounting Evidence
• Health Consequences
• Less Visible Barrier to Access
• Therapeutic Failure
• Prolonged Illness Death
• Global Microbial Resistance
• Loss of Confidence in the System
• Squandered Resources
• 43.5 billion annually

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Dimensions of the Problem

• Significant Growing Problem
• Definition
• World Health Organization
• U.S. FDA

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CounterfeitingDefinition

• a counterfeit medicine is one which is
  deliberately and fraudulently mislabeled 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,
  wrong ingredients, without active ingredients,
  with incorrect quantity of active ingredient or
  with fake packaging.
• World Health Organization (1997)

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Dimensions of the Problem

• Estimates HA!
• Magnitude of the Problem
• World Health Organization estimate 6 10
• Some developing nations more than 80
• Drugs Aspirin to Zyprexa
• Nations Global problem
• Financial Impact 43.5 billion/year
• Sophistication varied

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Dimensions of the ProblemDrug Quality

• In two studies analyzing counterfeit medications,
  the results show that
• 50 60 no active ingredient
• 15 20 wrong active ingredient
• 15 20 incorrect quantity of active
  ingredient
• 5 correct active ingredient

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Counterfeiting Specifics Examples
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Dimensions of the ProblemExamples

• Aspirin Because tablet-making machines are
  easily obtainable, even counterfeit aspirin
  tablets containing little or no acetylsalicylic
  acid can be profitable, especially at open-air
  markets such as those in African villages
• McGregor 1997

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Dimensions of the ProblemExamples

• HIV and Cancer Drugs drugs to boost the immune
  system of cancer and HIV patients have become a
  favorite of counterfeiters. In one case . . .
  criminals realized a 28 million profit from a
  shipment of 11,000 boxes of counterfeit Epogen
  and Procrit, which is also often prescribed to
  cancer, AIDS and kidney-failure patients
• Associated Press 2003

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Dimensions of the ProblemExamples

• Childrens Vaccines As many as 80,000
  children in Nigeria have gotten fake meningitis
  vaccines. India has seen bogus polio vaccines
• Knox 2003

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Dimensions of the ProblemExamples

• Ponstan Authorities interdicted millions of
  yellow tablets that were virtually
  indistinguishable from the genuine product
  including the company logo. These tablets were
  made of boric acid, floor wax, and lead-based
  yellow paint used for road markings. Sacks of
  these raw materials were stacked throughout the
  counterfeiters site
• Christian 2001

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Counterfeiting Operation
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Counterfeiters GMP
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Serostim
Source FDA website
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Viagra
In October 2002, 1,233 packages of unapproved
Viagra were found at the Miami international mail
facility. Over 80,000 tablets were found at JFK
airport. Counterfeit product found in Malaysia
it has appeared in Mexico. Counterfeit box and
tablet package is excellent. Replicated the
Pfizer logo, blister card, foil backing and
hologram. (Source PhRMA, Thanks to Dr. Marv
Shepherd)
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Zantac
Manufactured in Taiwan, discovered in United
Kingdom. Excellent packaging of counterfeit,
even includes counterfeit package insert.
(Source PhRMA, Thanks to Dr. Marv Shepherd)
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Deca-Durabolin
Counterfeit
Genuine
An anemia product used to treat renal
insufficiency was purchased in Mexico and
illegally imported to the U.S. Packaging is very
similar to original, but in testing the
counterfeit product, it only contained sesame
seed oil. (Source PhRMA, Thanks to Dr. Marv
Shepherd)
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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
PhRMA, Thanks to Dr. Marv Shepherd)
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Procrit
Three Batches of Counterfeit Procrit (epoetin
alfa) by Ortho Biotech, found March, 2003 Product
contained no active ingredient and may contain
bacterial contamination (Acinetobacter and
Pseudomonas). (Source Dr. Marv Shepherd)
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Prozac
Photos taken from a plant in Asia. Manufactured
in China, shipped to Taiwan and from there
shipped around the world. Package in counterfeit
Lilly blister packs. There is no assurance of
quality, manufacturing processes or conditions.
(Source Dr. Marv Shepherd)
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Manufacturing Facility for Counterfeit Panadol
(Source PhRMA Thanks to Dr. Marv Shepherd)
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Dimensions of the ProblemCommon Threads

• Small numbers of very costly drugs
• Large quantities of less costly drugs
• Expensive branded drugs
• Clear injectibles
• Simple tablets

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Facilitating FactorsWHOs List

• Counterfeiting is facilitated where
• weak drug regulatory control and enforcement,
• scarcity and/or erratic supply of basic
  medicines,
• extended, relatively unregulated markets and
  distribution chains,
• price differentials,
• lack of effective intellectual property
  protection,
• due regard is not paid to quality assurance
• World Health Organization 1992

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Facilitating FactorsThe Attraction

• Organized Crime
• Less Dangerous
• Less Risky
• Difficult Detection
• Naiveté of Law Enforcement
• Negligible punishment
• Enhanced IPRs
• Changing Technology

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Facilitating FactorsNegligible Punishment

• In Malaysia the maximum fine for manufacturing
  counterfeit medicine is 25,000 ringgit (6,580).
  . . The law also allows for a maximum three-year
  jail sentence, but a representative of the
  Pharmaceutical Association of Malaysia says no
  one has ever done time for making fake medicine
  in Malaysia
• Saywell McManus 2002

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Facilitating FactorsNegligible Punishment

• In Vietnam, 64 per cent of all artesunate (a key
  antimalarial drug in Southeast Asia) samples
  tested were found to be fake. Nevertheless,
  while prison terms of 20 years have been given
  in Vietnam for trading in fake sildenafil
  (Viagra) . . . there have been no prosecutions of
  fake antimalarial traders
• Newton et al. 2001

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Facilitating FactorsEnhanced IPR Protection

• Changing Market Conditions
• Increased Intellectual Property Rights
• Focus on two elements
• Access to medicines
• Research on neglected diseases
• Exacerbating the Problems of Counterfeiting
• First pass at Enforcement
• Wholehearted approach to Enforcement

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Facilitating FactorsChanging Technology

• Desktop Publishing
• Available Equipment on eBay
• Distinctive bottles replaced by uniform vials
• Internet sourcing

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Strategies for Combating Counterfeiting

• Parallel Imports
• Local Production
• Enforcement Efforts
• Education

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StrategiesParallel Imports

• Disappointing Results
• Israel, the Philippines and Kenya
• Low-priced markets see prices increase
• Evidence in EU
• Variety of Packaging

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StrategiesLocal Production

• DAP often did not advocate local production,
  particularly in countries with populations of
  less than 25 million . . . the value component in
  local-drug production was small and that quality
  and reliability of supplies were frequently
  questionable . . . DAP recommended that they
  start with packaging from bulk and only gradually
  move towards simple formulation of drugs
• Lauridsen 1997

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StrategiesLocal Production

• Self-sufficiency solution
• High Fixed Costs
• Supplies
• Questionable quality reliability
• Alternative Bulk Purchase Programs

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StrategiesEnforcement

• Technology
• Deter counterfeiters
• Facilitate authentication
• Raise the costs to the counterfeiter
• Security features
• Overt
• Covert
• Forensic

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Conclusions

• Critical Timing
• Important Tradeoff
• Access to safe medicines vs. rewards to
  innovation
• Vulnerable Populations
• Need for Change with Safeguards

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Thank you for your attention.