Transcript TRM's follow-up to the 'Recommendations' at the sessions

Counterfeiting: An overview
of problems and dangers
Dr Sabine Kopp
Quality Assurance and Safety: Medicines
World Health Organization
World Health Organization
Problem: Counterfeiting medicines is
a major public health concern
World Health Organization
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 mislabelled 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?
World Health Organization
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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World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
Counterfeiting:
increasingly sophisticated business
World Health Organization
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
World Health Organization
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
World Health Organization
National regulatory and inspection
systems
– --> 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…
--> or non-existent ….
World Health Organization
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 -> 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
World Health Organization
WHO’s 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
World Health Organization
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
World Health Organization
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.
World Health Organization
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
World Health Organization
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
World Health Organization
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
* International Conference
Authorities taskforce
establishment
ofof Drug
an Regulatory
international
World Health Organization
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/FinalPrinciplesforLegislation.pdf
World Health Organization
 3-5 December 2008: Third IMPACT
General Meeting,
Hammamet/Tunisia
 19-27 January 2009 EB/WHO
 18-23 May 2009 World Health
Assembly
World Health Organization
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.
World Health Organization
Who is/should be in IMPACT ?
All 193 WHO Member States and all major
international stakeholders, such as:
European Commission
World Health Organization
How does IMPACT work?
Secretariat: WHO
5 working groups, focusing on the areas where
weaknesses have been identified and action needs
to be taken at national and international level:
legislative and regulatory infrastructure
regulatory implementation
enforcement
technology
communication
World Health Organization
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
World Health Organization
Internet and medicines
http://www.who.int/medici
nes/docs/Medicines-onInternet-Guide.html
In addition to English,
already available in many
languages such as Spanish,
Italian, Estonian, Arabic etc.
World Health Organization
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
World Health Organization
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
World Health Organization
Conclusions
 Fighting counterfeit medicines
– Working together with all parties
concerned, nationally and
internationally, is the key!
World Health Organization
Further questions ??????
http://www.who/medicines
World Health Organization