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Week-in-Review editorial: European supply chain threatens patient safety

The EU Commission recently revealed that just over 2.7 million fake medicines were seized at EU borders in 2006 - a whopping rise of 384 per cent on the previous year

The EU Commission recently revealed that just over 2.7 million fake medicines were seized at EU borders in 2006 - a whopping rise of 384 per cent on the previous year.

Counterfeit medicines get into Europe on the internet and through other means, but a European Alliance for Access to Safe Medicines' (EAASM) report has shown that counterfeit medicines have reached UK patients through Parallel Pharmaceutical Trade (PPT).

Dr Jonathan Harper, a leading authority on counterfeit medicines and the European distribution chain, produced the independent report, reviewing the implications of the European distribution channels with regard to patient safety.

Harper's report was presented on 20 November in the European Parliament to MEPs and other public health stakeholders.

So far in 2007, there have been four Class 1 recalls made by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The drugs involved were Lilly's antipsychotic Zyprexa (olanzapine), Astra Zeneca's prostate cancer drug Casodex (bicalutamide) and sanofi-aventis and Bristol-Myers Squibb's blood platelet aggregation inhibitor Plavix (clopidogrel), which had two separate recalls.

Why the increase? The report identified a number of reasons why counterfeit medicines are reaching the EU market. Firstly, the veracity of medicinal products is harder to detect, compared with other types of counterfeited consumer goods.

I guess it's down to context. We kind of expect a Louis Vuitton bag bought from a guy in the street to be a fake. No surprises there. But we don't expect the same from our pharmacies or healthcare stakeholders. We tend to trust them.

While the magnitude of counterfeit pharmaceuticals is still reported as low (under one per cent) in many developed countries, such as Australia, Canada, Japan, New Zealand and the US, they are becoming increasingly affected as the practice of global outsourcing of manufacturing intensifies.

The Organisation for Economic Co-operation and Development (OECD) said: "A worrisome trend is that counterfeits are increasingly being detected as having entered the supply chain of some of the most regulated jurisdictions."

In a survey conducted by OECD among pharmaceutical manufacturers in 2005, one company reported an increase in the existence of counterfeit active pharmaceutical ingredients (APIs) and increased difficulties in distinguishing between the genuine and the counterfeit material.

One company surveyed said it detected counterfeit APIs originating in India in 33 countries. Another reported that counterfeits of its pharmaceutical products sourced in China were detected in 42 countries.

The fact that many pharmaceutical companies are relocating manufacturing bases to China and India and that APIs from those regions seem to be the cause of the problem, perhaps it's time Big Pharma realised saving money in this way may bring short-term gains, but in the long-term public health is being put at risk.

30th September 2008

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