Blue Sphere Health

Posts Tagged ‘Africa’

Global Anti-counterfeiting: Coordinated Action Against Fake Drugs

Globally-coordinated action involving 81 countries has led to dozens of arrests and the removal of websites believed to be selling counterfeit drugs. Operation Pangea 4 was coordinated by Interpol and involved regulatory and law enforcement authorities from around the world including the Metropolitan Police and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Like previous operations, close coordination was the key to success. The internet is a critical battleground in the war on fake medicines and the scale of cooperation involved in Pangea 4 and its precedents is encouraging. I know from personal contacts how much individual toil and commitment lies behind these initiatives, and we should congratulate all concerned. The same level of cooperation is starting to happen in the the authentication and traceability of genuine drugs. Serialization and epedigree initiatives, such as the measures outlined in the EU Falsified Medicines Directive this year, will gradually improve supply chain security. A layered authentication approach to security features on packaging and (where appropriate) the addition of physical-chemical identifiers in the formulation itself will make it harder for counterfeiters to keep up. I have discussed strategic frameworks here before and my new book has some discussion of the wider issues and available counter-measures. You can buy it direct via the button on the right of this page. There are no magic bullets against counterfeit drugs and we will probably have to accept that this crime can never be fully stamped out, but let’s take a moment to focus on what we CAN do. Operation Pangea 4, and the other coordinated initiatives now starting to happen, are a major step in the right direction. Photo: Interpol
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Africa: Dumping Ground for Dangerous Fake Drugs

The post below was written a year ago, but since the publication of my new book (“Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” Wiley, 2011) I wanted to revisit the subject. Some interesting initiatives are coming up on internet pharmacies and traceability (serialization) of drugs in Europe and the USA, but Africa and other developing regions are where the damage from fake drugs is at its worst. Africa is awash with counterfeits of all types, to a level not easily appreciated unless you see it with your own eyes. In one African capital a government official showed me boxes and boxes of different confiscated products such as shoes, pens, razors, batteries, shampoo and medicines. These items are usually shoddy at best – the ‘leather’ shoes are made of cardboard and dissolve in the rain, the pens only last two days. Sometimes the products are injurious – fake razor blades often have blunt or jagged edges. Counterfeits can also be lethal: fake artemisinin therapy may be a death sentence for a three-year-old whose malaria remains untreated. The industrial rise of many developing nations has led to a hierarchy of product safety: Developed > Fast Developing > Africa. In European and US markets we are concerned about fake products when we find them, but we have sophisticated monitoring and law enforcement systems that can spot even low levels of fake or sub-standard product. The true problem lies largely unreported in Africa which is at the bottom of the heap, deluged by low cost, poor quality goods and counterfeits. The same low-wage countries used by western brands to reduce production costs are now dumping large quantities of manufactured garbage into Africa. This does not just affect international brands. An African entrepreneur told me how he was put out of business when his locally-made toiletry products were copied by Asian counterfeiters. Even cheap items can be counterfeited profitably if the volume is high and the quality of the fake is low. Africa is now living with an epidemic of counterfeits to add to its other problems. This erodes daily life with petty inconveniences and wasted money but in the case of fake drugs the effect is much more severe. Some of the bigger, richer nations such as Nigeria can fight back on their own with some success. Regional coordination is also improving but the seizure of huge quantitities of fake medicines in coordinated operations such as Interpol’s recent Mamba III is probably only the tip of the iceberg. It doesn’t matter which statistics you believe about the global level of fake drugs. Personally I don’t believe any one number because they are all built on the sand of poor data rather than on solid statistical foundations. The average prevalence is not the point. One percent, ten percent, fifty percent, whatever. All just irrelevant numbers if your child is dead from a treatable disease because the drugs you bought in good faith turned out to be worthless fakes. The long-term success of health initiatives such as the Medicines for Malaria Venture, aimed at one of the major causes of death in Africa, will depend not just on scientific innovation and ensuring wider access to medicines but on protecting Africans from fake medicines. Some of the things Africa needs to combat counterfeit drugs are low profile, unglamorous and probably hard to excite donors about: customs support, anti-counterfeiting technology, better retail systems, pharmacist training, consumer education. Some of it is happening, but not enough and not quickly enough. African governments do not have the finances or the resources to cope on their own. Many Africans will remain trapped in poor health unless we in developed nations attach as much importance to securing the African healthcare system as we do to providing innovative new drugs. Photo by John Steven Fernandez from flickr Creative Commons
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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book