Presentation on theme: "The Deadly Implications of Substandard and Counterfeit Drugs"— Presentation transcript:
1The Deadly Implications of Substandard and Counterfeit Drugs Making a KillingThe Deadly Implications of Substandard and Counterfeit Drugs
2What 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.”
3Counterfeit drugsSubstandard drugs : the amount of active substance is lower than as statedFake drugs: contain no active substanceFalsified drugs: active substance is changed/replaced with other substance“Cheating”: traditional (herbal) medicine contains chemical/synthetic active substance but not declared
4Counterfeit and Substandard drugs COUNTERFEIT DRUGSSUBSTANDARD DRUGSWell-made drugs that are old or poorly stored, badly-made drugsWillfully mislabeled as to identity or source, but not always a trademark violationCounterfeit and Substandard drugs
5Counterfeit drugsThe 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.
6Medicines that could kill millions (New Scientist, 08 September 2005) In 1995 in Niger: people inoculated with fake meningitis vaccineIn 2001 in China: patients died after taking counterfeit drugsIn Africa: active substances of ART drugs are replaced with tranquilizersIn Mekong Region: 40% of artesunate (anti malarial drug) are fake.
7IndonesiaSales of counterfeit drugs: Rp.21 billion/year (Parulian Simandjuntak)Chemical substance is added to traditional medicines sold freely hazardous to healthChemically 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”
8The professionalsMany doctors are not aware of the existence of counterfeit drugsMany doctors and pharmacists cannot distinguish the counterfeit drugs from the originalNo information, education and training on this problem
9Why is there an increase in poor quality drugs? Low marginal cost, high demand and high marginal returnsHistorically weak rules preventing fakes; still poor enforcement of new ruleslow penalties for producers, traffickers and packagers, which is encourages the fake drug tradeCorruption lowers capture rates in many placesEnabled by:Complex and opaque supply chains, with many parties ignorant of good practiceConfusion over definitions (incorrect drug seizures - EU, anti-counterfeit laws conflating patents with trademarks)
11New Definitions Authorized/Registered Products Good standardSubstandardNot authorized/non-registered productsGood standard and labeling/trademark violation
12Non-counterfeit substandard drugs – some developing country estimates COUNTERFEIT DRUGSSUBSTANDARD DRUGSNon-counterfeitIndia – 95%Cambodia - 25%China – 65%Willfully mislabeled as to identity or source, often, but not always, a trademark violation
19Counterfeit GabantinDrugs 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.
20Source: Pharmaceutical Research Manufacturers Association Counterfeit ZantacManufactured in Taiwan, discovered in United Kingdom.Excellent packaging of counterfeit, even includes counterfeit package insert.Source: Pharmaceutical Research Manufacturers Association
21Counterfeit PonstanPonstan 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
22Counterfeit Patch—no active ingredient Authentic Ortho Evra Contraceptive Patch and packagingProperty of Marv Shepherd, University of Texas
24Viagra® (sildenafil)Which one is the fake drug?AUTHENTICFAKE
25Manufacturing 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
31Why 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 threatThreatens long-term innovation and development
32The Global Face of Bad Medicine COUNTRY/REGIONWHO/IMPACT ESTIMATEUnited States<1%EuropeUnited KingdomCOUNTRY/REGIONWHO/IMPACT ESTIMATERussia10%CIS20%China8%Indonesia25%India10-20%Nigeria16%Kenya30%Lebanon35%Cambodia13%Perhaps a bar graph would work better work here? Would probably be more interesting/convey the information more quickly
33Extent 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 DrugsIndia—it is estimated at 15 to 20% drugs are fake. (Script, April 16, 2003)ChinaBrazil (40% to 50% fake)Mexico (25% fake)PakistanBelizeChileSoutheast Asia Countries (30 to 50%)
37What can be done to combat counterfeiting? Legislation banning counterfeit products, approve budget to enforce such legislationIncrease penalties for counterfeitersIncrease enforcement efforts (including technical monitoring of quality at ports, randomly within country)Improve education of intermediaries in how to spot counterfeit productsReward whistleblowersProduct tracking (simplify supply chains?)
38WHO’s work in combating counterfeit medicines: Three strategies1. Providing tools, international norms, standards and guidelines to assist that medicines circulating in national and international commerce are safe, efficacious and of good quality2. Providing support to Member States to build national regulatory capacity3. Developing global activities to combat counterfeit medicines, in collaboration with all relevant stakeholders
39Milestones 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
40Milestones 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 Drugs1999: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 counterfeits2001: WHA Technical Briefing
41Milestones in WHO's work in anti-counterfeiting (3) :Several ICDRA* requests to WHO to assist Member States to adopt measures to combat counterfeit medicines2004:ICDRA requests WHO to work towards international convention on CF medicines:No consensus among Member States on international convention on CF medicinesFebruary – July 2006:Rome conference recommends establishment of an international taskforce. Terms of Reference and name (IMPACT) endorsed at second meeting in Rome
42Milestones in WHO's work in anti-counterfeiting (4) September 2006:Circular Letter announcing the establishment of IMPACT to Member StatesNovember 2006:First IMPACT General Meeting, Bonn - nominating IMPACT Chair and Vice-Chairs, Chairs of Working Groups, and establishment of a Work Plan for 2007December 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 disagreementDecember 2008:Third IMPACT General Meeting, Hammamet/Tunisia; "IMPACT definition" approved
43Milestones in WHO's work in anti-counterfeiting (5) 19-27 January 2009WHO 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 interest18-23 May 2009World Health Assembly - discussion postponed to WHA 2010
44IMPACT conceptual approach 1) IMPACT is a voluntary coalition of partners, with the purpose of coordinating international activities aimed at combating counterfeit medical products2) 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/consumers3) IMPACT is led by WHO (Chair, Secretariat) with a focus on the public health implications of counterfeiting rather than on IPR-related aspects4) IMPACT outputs include recommendations, policy advice and training materials that reflect consensus reached among IMPACT partners
45All 193 WHO Member States and major international partners are members of IMPACTEuropean Commission
46How does IMPACT work? Secretariat: WHO (in the Department of Essential Medicines and Pharmaceutical Policies, WHO, Geneva)Executive Secretary a.i.: Dr Sabine KoppFive IMPACT working groups:Technical areas where weaknesses were identified and action is required at national and international level:1) legislative and regulatory infrastructure2) regulatory implementation3) enforcement4) technology5) communication
47Political 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 productsUse by some countries and companies of the counterfeit argument for limiting free trade / competition / parallel tradeUse 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 healthConcerns from some parties that certain technical measures would be too costly, e.g. for OTC and generic medicinesMajor divisions in the WHO / EB and WHA, especially between USA/EU/Africa and L.America (Brazil)/Asia (India).
48Future … until WHA 2010 and beyond WHO:New programme in WHO/EMP: Anti-Counterfeit Medicines (ACM)Fund-raising and staffing for ACM and IMPACT related activitiesClose 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 2010IMPACT:Continuation of WHO involvement in IMPACT (chair, secretariat)Communication with IMPACT partners and working groups, IMPACT web site clearly separated from WHO/EMPRegional and 4th General IMPACT meetings organizedEnforcement activities with Interpol and national authorities