Have you noticed that we're not hearing folks in Washington, DC ask this question any more?
The Lancet 2008; 371:1551
DOI:10.1016/S0140-6736(08)60663-7
Editorial
Combating counterfeit drugs
Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.
If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.
The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.
This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem?
At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking.
Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters.
Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia.
The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters.
There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised.
The Lancet 2008; 371:1551
DOI:10.1016/S0140-6736(08)60663-7
Editorial
Combating counterfeit drugs
Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.
If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.
The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.
This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem?
At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking.
Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters.
Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia.
The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters.
There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised.
