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The real cost of counterfeit medicines
Newsdesk
The real cost of counterfeit medicines at-risk from malaria—the rural poor and migrant population—who are most likely to encounter counterfeit drugs. The Malaria Consortium estimates that some 60–70% of Cambodians obtain treatment from the private sector, where fake medications abound. Whether or not patients suspect that their antimalarials are fake (sometimes counterfeit medications are sold alongside genuine ones, but priced more affordably), the consequences of taking such products can be severe. It could mean death, of course. Then there is the issue of resistance. The relationship has not been proven, but it seems likely. Counterfeiters may include, say, 5% of active ingredient to mislead those tests that measure presence rather than quantity. This amounts to incomplete treatment. Counterfeits also weaken faith in genuine drug regimens, prompting changes in treatment-seeking behaviour that can exacerbate already tricky situations. “Cambodia is doing a lot of work in improving their capacity for testing drugs and taking action against counterfeiters”, Meek explains. This requires a cadre of trained inspectors, enough to have a deterrent effect, and concomitant strengthening of regulatory bodies. No small task, of course, but in the short term a scheme in which village-based volunteers are trained to dispense authenticated antimalarial medications seems to be paying dividends. The scheme addresses key reasons people turn to counterfeit drugs: access and availability. Take a sub-Saharan nation in which the pharmacies are concentrated in the cities. A merchant can travel from village to village selling fake medications. For the villagers, the system is cheap, convenient and confidential, and they can buy a few tablets at a time. For the merchant, it is an easy profit with little risk. After all, not all countries have legislated
www.thelancet.com/infection Vol 10 September 2010
against this trade, and in those that have, it is often regarded as a trademark infringement, for which the sanction is a small fine. Yet this is a criminal enterprise— traces of MDMA (ecstasy) in fake medications attest to the fact that the same machines used to press narcotics are hauled into service for counterfeit drugs—and it is a serious threat to public health. The Cambodian studies are rare exceptions: elsewhere the extent of the counterfeit trade is unknown. The consequences, on the other hand, can be for all to see. During its 1995 meningitis epidemic, Niger unknowingly inoculated some 50 000 citizens with a fake vaccine, resulting in 2500 needless deaths. The same year, dozens of children in Haiti died after consuming a paracetamol cough syrup that contained a poisonous chemical used in antifreeze. Antiretrovirals are another example of drugs that have drawn the attention of counterfeiters. “If you look for counterfeits, you’ll find them”, points out Hans Hogerzeil (WHO, Geneva, Switzerland). “The trend seems to be that we’re finding more and more”, he told TLID, but he noted that this could be down to improved detection methods. “It is extremely difficult to quantify the prevalence of counterfeiting around the world, or even in the USA”, states Ilisa Bernstein (Food and Drug
For WHO’s report on counterfeit drugs see http://www.oecd.org/dataoecd/ 43/17/35650095.pdf
2010 Getty Images
In April 2010, the Cambodian Ministry of Health announced that the previous 5 months had seen the enforced closure of nearly 65% of the illegal pharmacies operating in the country. The US Agency for International Development (USAID)backed Promoting the Quality of Medicines Programme—which is active in 30 nations—had gathered evidence that these pharmacies were a significant source of counterfeit and substandard medicines in Cambodia. 4 years earlier, Tropical Medicine and International Health published a study examining the authenticity of antimalarial drugs in Burma, Laos, Vietnam, Cambodia, and Thailand. The researchers purchased 188 packets labelled artesunate from vendors in the five countries, and found that 53% of the samples did not contain artesunate at all. The authors noted that the fake blister packets were “often hard to distinguish from their genuine counterparts”, adding that the previous few years had seen a sharp increase in the problem. “An alarmingly high proportion of antimalarial drugs bought in pharmacies and shops in mainland South East Asia are counterfeit”, they concluded. In 2006, a study restricted to Cambodia collected 488 sample antimalarial drugs, 27% of which failed thin layer chromatography and disintegration tests. “Counterfeiting is still a major problem in Cambodia”, says Sylvia Meek (Malaria Consortium, London, UK), “although the government is trying hard to deal with it.” The Thai authorities responded to similar concerns by debarring private shops from selling antimalarials—a measure that Meek believes is proving effective but isn’t practical for neighbouring Laos or Cambodia, where the need is greater and the public healthcare system is unable to ensure comprehensive access to the required drugs. Indeed, it is those who are most
An official examines medicine in a pharmacy on the Thai–Cambodian border
585
2010 Getty Images
Newsdesk
Shoppers buying smuggled, counterfeit medicine in Abidjan, Cote d’Ivoire
Administration, Silver Spring, MD, USA). “Counterfeiters have access to sophisticated technologies and are able to make very, very good copies of the real drug and packaging.” Even if a patient falls sick after taking a counterfeit drug, doctors may not always suspect that the drug is to blame. Besides, to get an accurate idea of the variety and scale of counterfeiting requires a study of an enormous size and detail; and given the adaptability of those involved in the trade, it could only provide an insight into the situation there and then. The pharmaceutical industry does its own research, but they do not tend to place their findings in the public domain lest it erode trust in authentic medications. So what estimates do exist? A 2005 Organisation for Economic Co-operation and Development report suggested the trade was worth at least US$32 billion per year, adding that by 2010 this figure might reach $75 billion, but the authors conceded that their figures were “guesstimates— [there’s] no hard data on incidence, prevalence, or economic burden”. In 2008, WHO affirmed that “many countries in Africa and parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be counterfeit”. Some experts place the value of the entire counterfeiting industry at $600 billion per year, up to 7% of international trade. But whereas the trade in fake 586
pharmaceuticals accounts for part of this figure, there are vital differences between this trade and that in, for example, counterfeit jeans It comes down to an issue of semantics, but it is one which colours the debate and often leads to producers of fake medicines facing punishments much too lenient for the severity of their crime. For counterfeit jeans, the trademark violation represents the entire infraction. But this is not how WHO defines counterfeit. “Counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source”, states WHO. Certainly, this entails a trademark violation but the important point is that the producers have hidden their identity: regulators have no way of monitoring drug quality. This, stresses Hogerzeil, is wholly different to those medications that violate patents. “There is a real fear in developing countries that the counterfeit discussion and legislation in rich countries is being used to frustrate generics”, he explains. The pharmaceutical industry often conflates the two issues, claiming that producing unapproved generics is tantamount to counterfeiting. “WHO is not bothered at all about any trademark infringement—that’s for other organisations to address— our concern is the public health”, Hogerzeil told TLID. Last year, authorities in the Netherlands and Germany used counterfeiting and intellectual property legislation to seize shipments of pharmaceuticals lawfully produced by countries that don’t recognise drug patent rights, mainly India. “We at WHO deplore these interceptions”, Hogerzeil said categorically. “We don’t want counterfeit legislation to be used to stop a generic product which is in itself perfectly legitimate in its trade.” Enacting enforceable and appropriate legislation is a crucial element of any national response. Countries should establish central reporting
systems, says Hogerzeil, so that they can collect data. Regulators need to disseminate information on counterfeiting to concerned parties, including neighbouring countries; and pharmacists have to be trained to recognise fake products. “It all fits within a general pattern of promoting regulation capacity”, affirms Hogerzeil. There’s an overspill into law enforcement, and at the beginning of this year Interpol—who have been active in tracing counterfeit medicines in southeast Asia back to their source factory—established a unit for Medical Products Counterfeiting and Pharmaceutical Crime. There are a lot of sectors that need to be coordinated here: medical regulatory authorities, pharmaceutical companies, law enforcement agencies, non-governmental organisations, and politicians. Counterfeit medications can also cross several borders on the way to their final destination. The seemingly impossible task of stemming the trade in narcotics hints at the magnitude of the task at hand. Then again, the fact that these drugs can be acquired legally offers an important tool to those fighting counterfeiters. “Price is extremely important to the people buying the drugs, especially in remote areas”, explains Meek. She points out that the Affordable Medicines Facility for Malaria could reduce the cost of treatment to around $0.1. “It could take away a lot of the incentive for counterfeiting.” Meek emphasises the need for international cooperation to tackle counterfeiting. Moreover, the emergence of artemisinin-resistant malaria in Cambodia adds urgency to the fight. “It’s really important that we do everything we can to reduce resistance”, she told TLID. “The association between fake drugs and resistance is hard to understand, but there’s a clear risk and if resistance spreads to Africa we will be set back by years.”
Talha Burki
www.thelancet.com/infection Vol 10 September 2010
The real cost of counterfeit medicines at-risk from malaria—the rural poor and migrant population—who are most likely to encounter counterfeit drugs. The Malaria Consortium estimates that some 60–70% of Cambodians obtain treatment from the private sector, where fake medications abound. Whether or not patients suspect that their antimalarials are fake (sometimes counterfeit medications are sold alongside genuine ones, but priced more affordably), the consequences of taking such products can be severe. It could mean death, of course. Then there is the issue of resistance. The relationship has not been proven, but it seems likely. Counterfeiters may include, say, 5% of active ingredient to mislead those tests that measure presence rather than quantity. This amounts to incomplete treatment. Counterfeits also weaken faith in genuine drug regimens, prompting changes in treatment-seeking behaviour that can exacerbate already tricky situations. “Cambodia is doing a lot of work in improving their capacity for testing drugs and taking action against counterfeiters”, Meek explains. This requires a cadre of trained inspectors, enough to have a deterrent effect, and concomitant strengthening of regulatory bodies. No small task, of course, but in the short term a scheme in which village-based volunteers are trained to dispense authenticated antimalarial medications seems to be paying dividends. The scheme addresses key reasons people turn to counterfeit drugs: access and availability. Take a sub-Saharan nation in which the pharmacies are concentrated in the cities. A merchant can travel from village to village selling fake medications. For the villagers, the system is cheap, convenient and confidential, and they can buy a few tablets at a time. For the merchant, it is an easy profit with little risk. After all, not all countries have legislated
www.thelancet.com/infection Vol 10 September 2010
against this trade, and in those that have, it is often regarded as a trademark infringement, for which the sanction is a small fine. Yet this is a criminal enterprise— traces of MDMA (ecstasy) in fake medications attest to the fact that the same machines used to press narcotics are hauled into service for counterfeit drugs—and it is a serious threat to public health. The Cambodian studies are rare exceptions: elsewhere the extent of the counterfeit trade is unknown. The consequences, on the other hand, can be for all to see. During its 1995 meningitis epidemic, Niger unknowingly inoculated some 50 000 citizens with a fake vaccine, resulting in 2500 needless deaths. The same year, dozens of children in Haiti died after consuming a paracetamol cough syrup that contained a poisonous chemical used in antifreeze. Antiretrovirals are another example of drugs that have drawn the attention of counterfeiters. “If you look for counterfeits, you’ll find them”, points out Hans Hogerzeil (WHO, Geneva, Switzerland). “The trend seems to be that we’re finding more and more”, he told TLID, but he noted that this could be down to improved detection methods. “It is extremely difficult to quantify the prevalence of counterfeiting around the world, or even in the USA”, states Ilisa Bernstein (Food and Drug
For WHO’s report on counterfeit drugs see http://www.oecd.org/dataoecd/ 43/17/35650095.pdf
2010 Getty Images
In April 2010, the Cambodian Ministry of Health announced that the previous 5 months had seen the enforced closure of nearly 65% of the illegal pharmacies operating in the country. The US Agency for International Development (USAID)backed Promoting the Quality of Medicines Programme—which is active in 30 nations—had gathered evidence that these pharmacies were a significant source of counterfeit and substandard medicines in Cambodia. 4 years earlier, Tropical Medicine and International Health published a study examining the authenticity of antimalarial drugs in Burma, Laos, Vietnam, Cambodia, and Thailand. The researchers purchased 188 packets labelled artesunate from vendors in the five countries, and found that 53% of the samples did not contain artesunate at all. The authors noted that the fake blister packets were “often hard to distinguish from their genuine counterparts”, adding that the previous few years had seen a sharp increase in the problem. “An alarmingly high proportion of antimalarial drugs bought in pharmacies and shops in mainland South East Asia are counterfeit”, they concluded. In 2006, a study restricted to Cambodia collected 488 sample antimalarial drugs, 27% of which failed thin layer chromatography and disintegration tests. “Counterfeiting is still a major problem in Cambodia”, says Sylvia Meek (Malaria Consortium, London, UK), “although the government is trying hard to deal with it.” The Thai authorities responded to similar concerns by debarring private shops from selling antimalarials—a measure that Meek believes is proving effective but isn’t practical for neighbouring Laos or Cambodia, where the need is greater and the public healthcare system is unable to ensure comprehensive access to the required drugs. Indeed, it is those who are most
An official examines medicine in a pharmacy on the Thai–Cambodian border
585
2010 Getty Images
Newsdesk
Shoppers buying smuggled, counterfeit medicine in Abidjan, Cote d’Ivoire
Administration, Silver Spring, MD, USA). “Counterfeiters have access to sophisticated technologies and are able to make very, very good copies of the real drug and packaging.” Even if a patient falls sick after taking a counterfeit drug, doctors may not always suspect that the drug is to blame. Besides, to get an accurate idea of the variety and scale of counterfeiting requires a study of an enormous size and detail; and given the adaptability of those involved in the trade, it could only provide an insight into the situation there and then. The pharmaceutical industry does its own research, but they do not tend to place their findings in the public domain lest it erode trust in authentic medications. So what estimates do exist? A 2005 Organisation for Economic Co-operation and Development report suggested the trade was worth at least US$32 billion per year, adding that by 2010 this figure might reach $75 billion, but the authors conceded that their figures were “guesstimates— [there’s] no hard data on incidence, prevalence, or economic burden”. In 2008, WHO affirmed that “many countries in Africa and parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be counterfeit”. Some experts place the value of the entire counterfeiting industry at $600 billion per year, up to 7% of international trade. But whereas the trade in fake 586
pharmaceuticals accounts for part of this figure, there are vital differences between this trade and that in, for example, counterfeit jeans It comes down to an issue of semantics, but it is one which colours the debate and often leads to producers of fake medicines facing punishments much too lenient for the severity of their crime. For counterfeit jeans, the trademark violation represents the entire infraction. But this is not how WHO defines counterfeit. “Counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source”, states WHO. Certainly, this entails a trademark violation but the important point is that the producers have hidden their identity: regulators have no way of monitoring drug quality. This, stresses Hogerzeil, is wholly different to those medications that violate patents. “There is a real fear in developing countries that the counterfeit discussion and legislation in rich countries is being used to frustrate generics”, he explains. The pharmaceutical industry often conflates the two issues, claiming that producing unapproved generics is tantamount to counterfeiting. “WHO is not bothered at all about any trademark infringement—that’s for other organisations to address— our concern is the public health”, Hogerzeil told TLID. Last year, authorities in the Netherlands and Germany used counterfeiting and intellectual property legislation to seize shipments of pharmaceuticals lawfully produced by countries that don’t recognise drug patent rights, mainly India. “We at WHO deplore these interceptions”, Hogerzeil said categorically. “We don’t want counterfeit legislation to be used to stop a generic product which is in itself perfectly legitimate in its trade.” Enacting enforceable and appropriate legislation is a crucial element of any national response. Countries should establish central reporting
systems, says Hogerzeil, so that they can collect data. Regulators need to disseminate information on counterfeiting to concerned parties, including neighbouring countries; and pharmacists have to be trained to recognise fake products. “It all fits within a general pattern of promoting regulation capacity”, affirms Hogerzeil. There’s an overspill into law enforcement, and at the beginning of this year Interpol—who have been active in tracing counterfeit medicines in southeast Asia back to their source factory—established a unit for Medical Products Counterfeiting and Pharmaceutical Crime. There are a lot of sectors that need to be coordinated here: medical regulatory authorities, pharmaceutical companies, law enforcement agencies, non-governmental organisations, and politicians. Counterfeit medications can also cross several borders on the way to their final destination. The seemingly impossible task of stemming the trade in narcotics hints at the magnitude of the task at hand. Then again, the fact that these drugs can be acquired legally offers an important tool to those fighting counterfeiters. “Price is extremely important to the people buying the drugs, especially in remote areas”, explains Meek. She points out that the Affordable Medicines Facility for Malaria could reduce the cost of treatment to around $0.1. “It could take away a lot of the incentive for counterfeiting.” Meek emphasises the need for international cooperation to tackle counterfeiting. Moreover, the emergence of artemisinin-resistant malaria in Cambodia adds urgency to the fight. “It’s really important that we do everything we can to reduce resistance”, she told TLID. “The association between fake drugs and resistance is hard to understand, but there’s a clear risk and if resistance spreads to Africa we will be set back by years.”
Talha Burki
www.thelancet.com/infection Vol 10 September 2010