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The Deadly Implications of Substandard and Counterfeit Drugs

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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

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