TRM's follow-up to the "Recommendations" at the sessions entitled "Herbal medicines" and

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Counterfeiting An overview of problems and
dangers
Dr Sabine Kopp Quality Assurance and Safety
Medicines World Health Organization
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Problem Counterfeiting medicines is a major
public health concern
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What is a counterfeit medicine?

• Different definitions in different countries!!!

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WHO Definition of a counterfeit medicine

• A product that is
• deliberately and fraudulently mis-labelled with
  respect to source and/or identity.
• Counterfeiting can apply to both
• generic and branded products.

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WHO Definition of a counterfeit medicine

• Counterfeit 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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What's a counterfeit medical product?
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WHO receiving reports on cases of counterfeit
medicines (1982)

• Majority of the reports did not distinguish
  between substandard and counterfeit medicines
• Most cases were not validated or confirmed
• Most sources of the counterfeit medicines were
  unknown

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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeiting increasingly sophisticated
business
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Counterfeit Lipitor (20mg tablets)

• Text should
• be facing
• downwards
• as above

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What is the problem?

• Counterfeiting medicines is a lucrative
  "business" and seems emerging, affecting both
  developing and developed countries
• The real magnitude of the problem is unknown
• Existing data not comprehensive
• All parties concerned reluctant to make data
  AVAILABLE or REPORT

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Is there a health risk ?

• Under treatment or non-treatment
• Public health risk ineffective medicines
• Intoxication harmful ingredients
• No quality assurance
• Adverse reactions not monitored an effective
  product recall not possible
• Erosion of public confidence in medical care and
  health systems
• Waste of money
• .

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

• Social value of medicines not given priority
  consideration when defining national drug
  policies
• Manufacturing without GMP compliance
• Poor storage and distribution condition

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

• Lack of government commitment to create strong
  medicines regulation
• Weak legislation
• MRAs week in terms of resources, expertise, and
  enforcement
• Presence of unregulated markets, manufacturing
  distribution outlets

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National regulatory and inspection systems

• --gt approx. 1/3 of WHO Member States have well
  developed regulatory systems, approx.. 1/3 have
  none
• In developed countries
• well organized, controlling national market
• dossiers evaluation and inspections
• different approaches used, few MRA
• In developing countries
• often difficulties of resources
• capacity?
• application of national and international
  guidelines
• --gt or non-existent .

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

• High prices and price differentials, health care
  providers and patients looking for cheaper
  sources
• In developing countries scarcity or erratic
  supply of medicines
• Lack of respect for trademark and other
  international agreements
• Corruption

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What are the main factors encouraging
counterfeiting of medicines globally? (IV)

• "Denial" of existence of problem by governments,
  industries, regulators, etc.
• International aspect of manufacture and supply of
  pharmaceuticals -gt difficult to control ?
  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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WHOs work in combating counterfeit medicines
Three strategies

• 1. Providing tools, international norms,
  standards and guidelines to assist that drugs
  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

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Pre-ICDRA Conference on Counterfeit Drugs,
Madrid, 13-14 February 2004

• ICDRA only for regulators, forum for 100
  regulatory authorities all around the World
• Pre-conference on counterfeit drugs was open to
  all stakeholders, participants included
• International organizations, e.g. Interpol, WIPO
  WCO
• Regulators (Australia, US, Thailand, China,
  Vietnam, the Netherlands..)
• Industry Associations IFPMA, WSMI
• Other NGOs

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Milestones in WHO's work in the
anti-counterfeiting area
Reports from WHO Member States early 80's
1988 Resolution WHA 41.16 requesting WHO to
initiate programmes for the prevention and
detection of the exportation, importation and
smuggling of counterfeit pharmaceutical products.

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1992 first international meeting on counterfeit
drugs organized by WHO, CIOMS and IFPMA
definition of 'counterfeit drug' and called all
parties involved in manufacturing and
distribution as well consumers to collaborate
with governmental institutions in combating
counterfeit drugs
Council for International Organizations of
Medical Sciences
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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
WHO, IFPMA, EGA, Pharmaciens Sans Frontières
working group on counterfeits 2001 WHA
Technical Briefing
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1994-2004 several ICDRA request WHO to assist
member states to adopt measures to combat
counterfeit medicines Madrid 2004 ICDRA
requested WHO to work at a draft international
convention on counterfeit medicines 2005-06 No
consensus among Member States on an international
convention on counterfeit medicines February
2006 Rome conference recommended establishment
of an international taskforce
International Conference of Drug Regulatory
Authorities
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July 2006 ToR and name (IMPACT) endorsed at
meeting in Rome September 2006 Circular Letter
announcing the establishment of IMPACT to Member
States November 2006 First IMPACT General
Meeting, Bonn, Germany - nomination of IMPACT
Chair and Vice-Chairs, nomination of Chairs of
IMPACT five Working Groups, and establishment of
a work plan for 2007. December 2007 Second
IMPACT General Meeting, Lisbon, Portugal
endorsement of "Principles and Elements for
National Legislation against Counterfeit Medical
Products"
http//www.who.int/entity/impact/events/FinalPrinc
iplesforLegislation.pdf
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• 3-5 December 2008 Third IMPACT General Meeting,
  Hammamet/Tunisia
• 19-27 January 2009 EB/WHO
• 18-23 May 2009 World Health Assembly

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IMPACT's conceptual framework 1) IMPACT
voluntary coalition of stakeholders that has the
purpose of coordinating international activities
aimed at combating counterfeit medical
products 2) IMPACT stakeholders reflect the
fact that combating counterfeiting of medical
products cannot be successfully achieved by the
health sector alone but requires 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, patients/consumers
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3) IMPACT is led by WHO to keep focus on the
public health implications of counterfeiting
rather than on IPR-related aspects.
4) IMPACT output include recommendations, policy
advice, and reference and training materials that
reflect consensus reached among IMPACT
stakeholders.
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Who is/should be in IMPACT ?
All 193 WHO Member States and all major
international stakeholders, such as
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How does IMPACT work?
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Issues that came up during the last 12 months

• Concerns that the fight against counterfeit
  medicines may have a negative impact on generics
• Use of the counterfeit argument for limiting free
  trade / competition / parallel trade
• Use of the term "counterfeit medicinal product"
  in patent disputes
• Concerns from some parties that technical
  measures would be too costly, e.g. for OTC and
  Generics

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Internet and medicines
http//www.who.int/medicines/docs/Medicines-on-Int
ernet-Guide.html In addition to English, already
available in many languages such as Spanish,
Italian, Estonian, Arabic etc.
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Questionnaire on Pharmaceutical e-trade in 2000
(58 out of 191 responded )

• Only 5 countries declared to specifically
  regulate promotion and sale through the Internet,
  but
• Wide range of sanctions
• - revocation of licence
• - confiscation of drugs
• - prison (1month -7years)
• - financial sanctions
• Very few countries effectively control
  exportation
• Importation via Internet is often accepted for
  personal use
• Published in WHO Drug Information Vol. 15 No. 3
  4, 2001 p 180

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What to recommend to patients ?

• Buy medicines from licensed pharmacies
• Examine the package to see if sealed
• Check the label for name, manufacturer, expiry
  date and instructions of use
• Avoid buying loose tablets, capsules or
  injections
• Insist on having a receipt
• See your doctor/healthcare provider if symptoms
  persist
• If you suspect counterfeiting, report to your
  pharmacy and healthcare provider or medicine
  control authorities

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Conclusions

• Fighting counterfeit medicines
• Working together with all parties concerned,
  nationally and internationally, is the key!

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Further questions ??????

• http//www.who/medicines