Counterfeit drugs: Threat to Public Health

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Counterfeit drugs Threat to Public Health
The Global Forum on Pharmaceutical
Anticounterfeiting Noga Hilton Hotel, Geneva,
Switzerland 22-25 September 2002
Lembit Rägo, MD, PhD Coordinator, Quality
Assurance and Safety Medicines Essential Drugs
and Medicines Policy Health Technology and
Pharmaceuticals Cluster World Health
Organization E-mail ragol_at_who.ch
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Counterfeit drugs range from direct copy to a
dosage form with none of the active ingredients
However, no unified definition USA A drug
which, or the container or labelling of which
without authorisation bears the trademark, trade
name, other identifying mark, imprint, or device
or any likeness thereof, of a drug manufacturer,
processor, packer, or distributor other than the
person or persons who in fact manufactured,
processed, packed, or distributed such drug and
which thereby falsely purports or is falsely
represented, to be the product of, or to have
been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor.
(US Food, Drug and Cosmetic Act)
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Counterfeit drugs range from direct copy to a
dosage form with none of the active ingredients
Philippines A drug deliberately fraudulently
mislabelled with respect to its source and/or
identity a product with insufficient amount of
active ingredients a product with wrong
ingredients the drug or the container or
labelling bearing without authorisation
trademark, trade name or other identification
mark or imprint or any likeness to that
registered unregistered-imported product A
product containing less than 80 of the labelled
amount A product refilled in a container by
unauthorized person if the legitimate labels or
marks are used (Republic Act No. 8203, 1996)
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A common definition is needed to promote common
understanding coordinated actions
WHO A product that is deliberately and
fraudulently mislabelled with respect to source
and/or identityCounterfeiting can apply to both
generic and branded productsCounterfeit products
may include products with the correct
ingredients with the wrong ingredients without
ingredients with incorrect quantities of active
ingredients with fake packaging
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WHO has been receiving reports on cases of
counterfeit drugs since 1982

About 70 of the cases were reported by
developing countries Less than 30 came from
developed countries Countries that send reports
are less than 10-15 of WHO Member
States Majority of the reports received do not
make distinction between substandard and
counterfeit drugs Most cases have not been
validated or confirmed The sources of the
counterfeit drugs are unknown
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Between 2000-2001 42 cases of counterfeit drugs
were reported to WHO
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The therapeutic categories of the counterfeit
drugs reported between 2000-2001
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Types of counterfeits reported included the
following
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Both branded and generic products are
counterfeited
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(No Transcript)
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Illegal manufacturing is one of the causes
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The problem is increasing and it is affecting
developed and developing countries (I)

• Diethylene glycol poisoning in Gurgaon India -
  36 children affected (most of them died) (1998)
• Dummy contraceptive pills false anticancer
  drugs in Brazil (1998)
• Counterfeit pharmaceutical factory located in
  India,1998
• Fake ofloxacin (Tarivid) in Hong-Kong
  contained-glucose and penicillin (1998)

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The problem is increasing and it is affecting
both developed and developing countries (II)

• Counterfeit artesunate and mefloquine in
  Cambodia- 8 people died (1999)
• 240,000 packs of medicines and 2 tonnes of raw
  materials worth 1 million US seized in Italy
  (2000)
• In Russia the number of cases of counterfeit
  drugs has increased 10 times since 1998. It
  reached 150 in 2000.
• Counterfeit Serostim, Neupogen and Nutropin AQ
  found in USA, 2001

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What are the main factors encouraging
counterfeiting of drugs? (I)

• Social value of drugs not given priority
  consideration in defining national drug policies
• manufacturing without GMP compliance, poor
  storage and distribution condition
• Lack of government commitment to create strong
  drug regulation
• Weak legislation, DRAs week in terms of
  resources, expertise, and enforcement
• Presence of unregulated markets-manufacturing
  distribution outlets

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What are the main factors encouraging
counterfeiting of drugs? (II)

• Scarcity or erratic supply of drugs - smuggling
  and counterfeiting
• High prices and price differentials-poor patients
  look for cheaper sources - attracts
  counterfeiters
• Lack of respect for trademark and other
  international agreements
• Corruption

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What are the main factors encouraging
counterfeiting of drugs? (III)

• Denial of the existence of the problem by
  governments, industries, regulators,etc
• International aspect of the manufacture and
  supply of pharmaceuticals makes it difficult to
  control-control is multi-jurisdictional
• New trade arrangements-
• opening of boarders for trade
• trade through free ports, trade through several
  intermediaries
• promotion and trade through Internet

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What can be done to combat the problem?

• Undertake advocacy activities targeted at
  government decision - makers to increase
  awareness and gain political support for strong
  drug regulation
• Advocacy and educational campaign programmes
  aimed at the general public
• Campaign to ensure that export drugs are
  regulated to the same standard as drugs
  domestically used
• Campaign for the creation of an international
  organ to control trade in counterfeit drugs

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What is WHO doing to fight counterfeit drugs? (I)

• Guidelines for the development of measures to
  combat counterfeit drugs 1999
• A study Counterfeit and substandard drugs in
  Myanmar and Vietnam published 1999
• Workshops and meetings on counterfeit drugs
  involving industry and international agencies
  have been organised regularly at international /
  regional level - With IFPMA in 1992 and 1997
  Vietnam 1998 Ghana 2000, Kenya 2001, Cambodia
  2001
• Training workshops for drug regulators in all WHO
  regions on drug registration, on GMP laboratory
  testing

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What is WHO doing to fight counterfeit drugs? (II)

• Working Group which includes WHO, international
  pharmaceutical associations (IFPMA, WSMI, IGPA)
  and NGOs (CHMP) was created 1999
• Technical briefing on counterfeit drugs during
  53rd WHA in 2000
• Poster, videotape and fact sheet to raise
  awareness of the problems prepared and
  distributed
• survey in one country on-going

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What is WHO doing to fight counterfeit drugs?
(III)

• Project with support from Australian Govt. for
  Mekong Delta countries - Cambodia, China, Laos,
  Myanmar,Thailand and Viet Nam
• development of common advocacy strategy
• development of deterrent legislation
• strengthening post-marketing surveillance
• training of inspectors to monitor the incidence
  of counterfeit drugs.

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• Combating counterfeits?
• Working together is the key !