Microsoft powerpoint - amnesty counterfeiting presentation

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overview of the issues for AmnestyInternational, Niagara Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
Medicines which have been deliberately and fraudulently mislabelled with respect to
identity and/or source
can apply to branded and generic medicines n correct ingredients but fake packagingn wrong ingredientsn without active ingredientsn insufficient active ingredients diversion is the practice of moving a product internationally without the approval of thebrand-owner counterfeits may be substituted as part of the diversion process substandard medicines are those that fail to meet correct scientific specifications may result from legitimate manufacturers producing a poor product, but withoutthe intent to defraud or misrepresent Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
licensed
End-users
companies
governments
Originators of
(patients,
and regulators
Dispensers of
medicines
parents,
medicines to
of medicines
medicines
(manufacturers)
consumers,
purchasers and
informal carers)
end-user
priorities
Counterfeit medicines areembedded in a very complex system Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
WHO estimates that 25% of drugs in developing countries and 8-10% of the global supply of medicines arecounterfeits international trade in counterfeit medicines is estimated at US$80 billion 11 Chinese nationals and one American arrested for counterfeiting scheme that spanned 11 countries,440,000 bogus pills and US$4.3 million: Lipitor, Viagra, Cialis, Levitra, to US, UK, Switzerland, Israel Registered pharmacist in Hamilton sold counterfeit Norvasc and allegedly contributed to the deaths of 5people China had perhaps 500 illegal drug factories in 2001, while in the same year 1300 were closed whileinvestigating 480,000 cases of counterfeit drugs worth $57 million in China, between 50 and 85 percent of products have a counterfeit prevalence 36.5% of antibiotics and anti-malarials on WHO list of essential drugs are substandard in Thailand andNigeria Mexico is a major source of counterfeits, with trade estimated at US$650 million per year Counterfeits comprise 5-10% of drugs in Russia 2002 study showed 9% of medicines in India were substandard between 20 and 90 percent of anti-malarials in 7 African countries failed quality testing top counterfeited drugs in Philippines include: antihypertensive drugs (Adalat), anti-asthma (Ventolin),analgesics (Ponstan), anti-diarrhoea (Diatabs), vitamins (Propan Iron, Enervon C) Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
335 Rx were dispensed at a cost of $14 billion n if Canada were as risky as Nigeria, about 120 million would be counterfeitn if Canada were as risky as Russia, about 33.5 million would be counterfeitn if Canada were as risky as the average WHO estimate: about 16 million n if Canada only 0.1% of Rx were counterfeit, then perhaps 350,000 would be Medicines regulators in the EU suspect that 5-10% may be counterfeit, but they really don’tknow because there aren’t accurate figurescollected Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
What makes counterfeit medicines a challenge? n Lack of consensus whether the problem is about: n patient safety & public health threatsn criminal activityn intellectual property & patents n fragmented/missing rules and systemsn gaps in regulation and oversightn failure of international action n No one group can own the problem n crosses boundaries of knowledge, jurisdictions, organisations Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
Ease of access to medicines in a liberal regime makes protection more difficult Drug-reimbursement policies which force patients into the ‘cash’ market lack of comprehensive a PharmaCare Plan (or equivalent) Few, if any pharmacies, have the ability to detect counterfeit medicines International trade in medicines lacks regulation and safety requirements individual countries responsible for standards and safety at point of importation andcannot inspect off-shore manufacturing facilities so rely on other countries forcompliance National regulators have poor information on scale of problem Regulatory actions are punitive and drive the problem underground Regulators cannot collectively agree on what to do Hospitals do not check if medicines are counterfeit when patients have bad drug reactions Conflict over jurisdiction between official bodies (police, customs, etc.) Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
n Most classes of drugs and medical products are now targets for counterfeiters Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
n Ineffectiven Harmfuln Resistance – esp malaria and HIV/AIDSn Bird Flu issues (poultry vaccinations/ tamiflu)n Undermines incentives for innovative R&Dn Drug diversion n Versions of (often on-patent) medicines exported from lower income countries and imported into wealthier countries n Anti-impotencyn Anti-obesityn Cholesteroln Anti-anaemian Globulin Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
n Consumers are powerless to gain redressn Pharma companies unable to protect their brand particularly in developing and n Less ability to control product through supply chain making criminal n Leakage into wealthy markets as drugs are reimportedn Criminals incentivised to move into counterfeiting as penalties are light and risk And of course let’s not forget that people don’t benefit from the medicines, get sicker and often die Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
n Improve property laws in weak countries to protect medicines bettern Improved enforcement of the lawsn Improve surveillance of the medicines trade (but has criminal law stopped the n Improve/fix the way people buy their medicines n cash markets??n Internet pharmacies??n Cheap and cheerful bargains?? Generated by Foxit PDF Creator Foxit Softwarehttp://www.foxitsoftware.com For evaluation only.
n Significant problems exist in developing countries in contrast to the relatively low number of incidents in OECD countries n that no event of signficance has taken place in should not be seen as justifying n the loss of public trust in the safe supply of medicines is not acceptable.
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Coincidence or Crisis? Prescription Medicine Counterfeiting, Peter Pitts, Mike Tremblay and others, StockholmNetwork, 2006.
www.stockholm-network.org/publications/list.php?p=3 Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply, Katherine Eban, Harcourt, 2005.
A Sick Business, Graham Satchwell, Stockholm Network, London 2004.
www.stockholm-network.org/publications/list.php?p=12 Counterfeit Medicines in Less Developed Countries, Julian Morris and Philip Stevens, International Policy Network,London, 2006.
WHO: www.who.int/mediacentre/factsheets/fs275/en/ European Union:europa.eu/rapid/pressReleasesAction.do?reference=MEMO/06/421&format=HTML&aged=0&language=en&guiLanguage=en Council of Europe: assembly.coe.int/Main.asp?link=/Documents/WorkingDocs/Doc07/EDOC11193.htm

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