1. The Deadly Implications of Substandard and Counterfeit Drugs
Making a Killing
The Deadly Implications of Substandard and Counterfeit Drugs

2. What is a counterfeit drug?
WHO’s definition:
“A counterfeit drug is a drug that has been deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and…may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

3. Counterfeit drugs
Substandard drugs : the amount of active substance is lower than as stated
Fake drugs: contain no active substance
Falsified drugs: active substance is changed/replaced with other substance
“Cheating”: traditional (herbal) medicine contains chemical/synthetic active substance but not declared

4. Counterfeit and Substandard drugs
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
Well-made drugs that are old or poorly stored, badly-made drugs
Willfully mislabeled as to identity or source, but not always a trademark violation
Counterfeit and Substandard drugs

5. Counterfeit drugs
The most counterfeited drugs in the developed countries (e.g. USA): high volume and expensive drugs, like antiretroviral, anti impotency, and psychiatric medicines.
The most counterfeited drugs in developing countries: high volume but not necessarily expensive, such as: paracetamol, anti malarial drugs, vaccines.

6. Medicines that could kill millions (New Scientist, 08 September 2005)
In 1995 in Niger: people inoculated with fake meningitis vaccine
In 2001 in China: patients died after taking counterfeit drugs
In Africa: active substances of ART drugs are replaced with tranquilizers
In Mekong Region: 40% of artesunate (anti malarial drug) are fake.

7. Indonesia
Sales of counterfeit drugs: Rp.21 billion/year (Parulian Simandjuntak)
Chemical substance is added to traditional medicines sold freely  hazardous to health
Chemically active substance sold as “traditional medicine” or “food supplements” through MLM (BPOM/Depkes are not aware?)
“Cheating” or “misleading information”, like “tolak angin” and “obat panas dalam”

8. The professionals
Many doctors are not aware of the existence of counterfeit drugs
Many doctors and pharmacists cannot distinguish the counterfeit drugs from the original
No information, education and training on this problem

9. Why is there an increase in poor quality drugs?
Low marginal cost, high demand and high marginal returns
Historically weak rules preventing fakes; still poor enforcement of new rules
low penalties for producers, traffickers and packagers, which is encourages the fake drug trade
Corruption lowers capture rates in many places
Enabled by:
Complex and opaque supply chains, with many parties ignorant of good practice
Confusion over definitions (incorrect drug seizures - EU, anti-counterfeit laws conflating patents with trademarks)

10. A Silver Lining

11. New Definitions Authorized/Registered Products
Good standard
Substandard
Not authorized/non-registered products
Good standard and labeling/trademark violation

12. Non-counterfeit substandard drugs – some developing country estimates
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
Non-counterfeit
India – 95%
Cambodia - 25%
China – 65%
Willfully mislabeled as to identity or source, often, but not always, a trademark violation

13. Faking an Indian Brand

14. Fake on Right

15. Lipitor® (atorvastatin calcium)
Which one is the counterfeit Lipitor®?
Source: Pfizer Inc.

16. Lipitor® (atorvastatin calcium)
Which one is the counterfeit Lipitor®?
FAKE
AUTHENTIC
Source: Pfizer Inc.

17. COUNTERFEIT AUTHENTIC Celebrex® (celecoxib) Which one is the fake?
Source: Pfizer Inc.

18. Counterfeit Operations

19. Counterfeit Gabantin
Drugs purchased over the Internet by an American patient who was told that the products were manufactured in the United States and were being sold from Canada. The drugs he actually received are fake “knockoffs” from India.

20. Source: Pharmaceutical Research Manufacturers Association
Counterfeit Zantac
Manufactured in Taiwan, discovered in United Kingdom.
Excellent packaging of counterfeit, even includes counterfeit package insert.
Source: Pharmaceutical Research Manufacturers Association

21. Counterfeit 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: Pharmaceutical Manufacturer Research Association

22. Counterfeit Patch—no active ingredient
Authentic Ortho Evra Contraceptive Patch and packaging
Property of Marv Shepherd, University of Texas

23. Viagra® (sildenafil)
Which one is the fake drug?

24. Viagra® (sildenafil)
Which one is the fake drug?
AUTHENTIC
FAKE

25. Manufacturing Facility for Counterfeit Panadol
This facility depicts the conditions in which many counterfeits are manufactured. This counterfeit lab was found in South East Asia.
Source: Pharmaceutical Research Manufacturers Association

26. Counterfeit Operations

27. Counterfeit Operations

28. Counterfeit Operations

29. Counterfeit Operations

31. Why is counterfeiting a problem?
Public health threat:
Direct: Fake drugs containing harmful ingredients (e.g. heavy metals)
Indirect: Drugs with inadequate or wrong active ingredients have no curative power (e.g. many malaria deaths)
Wider Impacts: Drugs with only some of the correct ingredients can cause a patient to develop resistance to that particular drug, making it harder for the patient (and potentially the population as a whole) to be treated with effective medicines later on (drugs for TB, HIV, malaria badly affected).
Intellectual property/brand integrity threat
Threatens long-term innovation and development

32. The Global Face of Bad Medicine
COUNTRY/
REGION
WHO/IMPACT ESTIMATE
United States
<1%
Europe
United Kingdom
COUNTRY/
REGION
WHO/IMPACT ESTIMATE
Russia
10%
CIS
20%
China 8%
Indonesia
25%
India
10-20%
Nigeria
16%
Kenya
30%
Lebanon
35%
Cambodia
13%
Perhaps a bar graph would work better work here? Would probably be more interesting/convey the information more quickly

33. Extent of Counterfeit Drugs and Major Sources
It has been estimated by the WHO that counterfeit drugs comprise 8 percent of the world market.
For some countries (African, Latin) counterfeits comprise 40 to 50 percent of the market.
Estimated to be $20 to over a $40 billion market. (WHO)
Sources of Counterfeit Drugs
India—it is estimated at 15 to 20% drugs are fake. (Script, April 16, 2003)
China
Brazil (40% to 50% fake)
Mexico (25% fake)
Pakistan
Belize
Chile
Southeast Asia Countries (30 to 50%)

37. What can be done to combat counterfeiting?
Legislation banning counterfeit products, approve budget to enforce such legislation
Increase penalties for counterfeiters
Increase enforcement efforts (including technical monitoring of quality at ports, randomly within country)
Improve education of intermediaries in how to spot counterfeit products
Reward whistleblowers
Product tracking (simplify supply chains?)

38. WHO’s work in combating counterfeit medicines:
Three strategies
1. Providing tools, international norms, standards and guidelines to assist that medicines 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, in collaboration with all relevant stakeholders

39. Milestones in WHO's work in anti-counterfeiting (1)
1988: Resolution WHA requests WHO to initiate programmes for prevention and detection of exportation, importation and smuggling of counterfeit medicines 1992: First international meeting on counterfeit drugs organized by WHO, CIOMS and IFPMA gives first definition of 'counterfeit drug'  called all parties involved in manufacturing and distribution as well consumers to collaborate with governmental institutions in combating counterfeit drugs  called all parties involved in manufacturing and distribution as well consumers to collaborate with governmental institutions in combating counterfeit drugs

40. Milestones in WHO's work in anti-counterfeiting (2)
1994:
Resolution WHA 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.
: WHO, IFPMA, EGA, PSF Working group on counterfeits
2001: WHA Technical Briefing

41. Milestones in WHO's work in anti-counterfeiting (3):
Several ICDRA* requests to WHO to assist Member States to adopt measures to combat counterfeit medicines
2004:
ICDRA requests WHO to work towards international convention on CF medicines :
No consensus among Member States on international convention on CF medicines
February – July 2006:
Rome conference recommends establishment of an international taskforce. Terms of Reference and name (IMPACT) endorsed at second meeting in Rome

42. Milestones in WHO's work in anti-counterfeiting (4)
September 2006:
Circular Letter announcing the establishment of IMPACT to Member States
November 2006:
First IMPACT General Meeting, Bonn - nominating IMPACT Chair and Vice-Chairs, Chairs of Working Groups, and establishment of a Work Plan for 2007
December 2007:
Second IMPACT General Meeting, Lisbon – endorsement of "Principles and Elements for National Legislation"
May 2008:
Discussion of WHO report and draft resolution in WHA; much disagreement
December 2008:
Third IMPACT General Meeting, Hammamet/Tunisia; "IMPACT definition" approved

43. Milestones in WHO's work in anti-counterfeiting (5)
19-27 January 2009
WHO Executive Board requests WHO to prepare two background documents for WHA in May 2009: (1) WHO's activities in substandard and counterfeit medicines; (2) IMPACT and potential conflict of interest
18-23 May 2009
World Health Assembly - discussion postponed to WHA 2010

44. IMPACT conceptual approach
1) IMPACT is a voluntary coalition of partners, with the purpose of coordinating international activities aimed at combating counterfeit medical products
2) IMPACT partners reflect the fact that combating counterfeiting of medical products cannot be successfully achieved by the health sector alone but requires a 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, and patients/consumers
3) IMPACT is led by WHO (Chair, Secretariat) with a focus on the public health implications of counterfeiting rather than on IPR-related aspects
4) IMPACT outputs include recommendations, policy advice and training materials that reflect consensus reached among IMPACT partners

45. All 193 WHO Member States and major international
partners are members of IMPACT
European Commission

46. How does IMPACT work? Secretariat:
WHO (in the Department of Essential Medicines and Pharmaceutical Policies, WHO, Geneva)
Executive Secretary a.i.: Dr Sabine Kopp
Five IMPACT working groups:
Technical areas where weaknesses were identified and action is required at national and international level:
1) legislative and regulatory infrastructure
2) regulatory implementation
3) enforcement
4) technology
5) communication

47. Political issues arising during the past 12 months
Concerns by many developing countries that the fight against counterfeit medicines may have a negative impact on free trade in generic products
Use by some countries and companies of the counterfeit argument for limiting free trade / competition / parallel trade
Use of the term "counterfeit medicinal product" in patent disputes; suggesting that the term counterfeit medicines should exclusively be used for IPR disputes and not for public health
Concerns from some parties that certain technical measures would be too costly, e.g. for OTC and generic medicines
Major divisions in the WHO / EB and WHA, especially between USA/EU/Africa and L.America (Brazil)/Asia (India).

48. Future … until WHA 2010 and beyond
WHO:
New programme in WHO/EMP: Anti-Counterfeit Medicines (ACM)
Fund-raising and staffing for ACM and IMPACT related activities
Close collaboration of ACM with regulatory and quality assurance programmes and WHO Expert Committee (IMPACT documents on distribution chain and model legislative text)
Communication with Member States to prepare for WHA 2010
IMPACT:
Continuation of WHO involvement in IMPACT (chair, secretariat)
Communication with IMPACT partners and working groups, IMPACT web site clearly separated from WHO/EMP
Regional and 4th General IMPACT meetings organized
Enforcement activities with Interpol and national authorities

49.
Thank you!
The Essential
Medicines family