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Vast profits and light jail sentences are two key reasons why the global trade in counterfeit medicines is attracting growing interest from organised crime groups.
Globally, sales of counterfeit drugs are expected to reach $75 billion (£38 billion) by 2010, a 92 per cent increase from 2005, according to America’s Centre for Medicines in the Public Interest. The World Health Organisation estimates that up to 10 per cent of medicines available globally are counterfeits.
In Nigeria up to 70 per cent of drugs are thought to be counterfeit or adulterated. In Russia and many of the former Soviet Republics the figure is thought to be well over 10 per cent. In the European Union counterfeit drugs constitute less than 1 per cent of the total. However, in 2005, Customs officers still seized more than half a million packets of fake medicines in 148 raids.
Yesterday European drug companies unveiled plans for new measures to stop the trade, including the launch of a pilot scheme which will use two-dimensional bar codes and tamper-resistant packaging. Electronic tags are also being considered.
GlaxoSmithKline, one of the world’s largest drugs companies, discovered a counterfeiting operation making fake GSK products, including antibiotics and pain relievers, at a plant in northeastern China. These were then supplied to customers in Africa, Asia, the Middle East and South America. But despite the scale of the operation and the huge sums involved, the ringleader was jailed for only a few months.
In Europe much of the concern over counterfeits revolves around the so-called “parallel trade” in medicines – a practice where drug wholesalers buy lower-cost pharmaceuticals in one country, for example Greece or Portugal, and then export them for sale in another EU country such as the UK, where they command a higher price. The wholesaler then pockets the difference.
Parallel trade is legal in the EU but wholesalers usually have to repackage the medicines in order to comply with regulations governing their sale in different countries, as well as the translation of the accompanying instructions into new languages.
This repackaging process represents a weak point where counterfeit drugs can be inserted into the supply chain and passed off as bona fide imports.
Critics of parallel trade, including big pharmaceutical companies whose profits are damaged by the practice, have been fighting a lengthy legal battle against it in the EU, citing the danger of counterfeits.
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Parallel trade is diversion selling products intended for one market into another market so as to arbitrage price differences between products sold at different prices in different countries.
Here in the US, diversion is the entry point for every case investigated by the FDA involving counterfeit drugs going into legitimate pharmacies. Unfortunately, while diverted or resold products are not necessarily counterfeits, all counterfeits enter via diversion in the secondary market.
Furthermore, Intermediaries (wholesalers and importers/exporters) absorb much of the inter-country price difference.
Thus, manufacturers and consumers bear the risks and costs of parallel trade importation, but get little of the supposed price savings.
If you care to learn more, I've written extensively about these issues on my blog:
http://www.drugchannels.net/search/label/Importation
Adam
http://www.drugchannels.net
Adam J. Fein, Philadelphia, PA/USA
Whilst these forgeries relate to products still in patent, there is increasing evidence that many generic preparations are not of equivalent quality to the original research based product.
However, it is impossible to obtain bioequivalence data for generic copies as the MHRA do not respond to requests for comparative information.
With some products, such as dispersible asprin, it is simple to check quality as a number of preparations barely
or only partially disperse.
Many patients both in the UK and in Portugal demand generic products of specific manufacturers due to experience of unusual side effects and variable efficacy.
It would appear that the quest for cheapness rather than therapeutic efficacy is the root cause of these problems.
Laurie, Faro, Portugal