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EU supply chain helps counterfeits

The European Alliance for Access to Safe Medicines publishes a report detailing Parallel Pharmaceutical Trade in Europe and its effects on counterfeit drugs

Campaigning group, the European Alliance for Access to Safe Medicines (EAASM), has published a report detailing Parallel Pharmaceutical Trade (PPT) in Europe and its effects on counterfeit drugs.

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

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

The EU Commission recently revealed that just over 2.7 million counterfeit medicines were seized at EU borders in 2006, an increase of 384 per cent on articles seized in 2005 (560,568).

The report cites evidence that counterfeit medicines are now firmly established in the EU supply chain and are not just confined to CEE states, as is commonly perceived.

So far in 2007, four Class 1 recalls have been made by the UK's Medicines and Healthcare products Regulatory Agency (MHRA): 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 was recalled twice.

Harper explained: "PPT complicates the EU supply chain in myriad ways. Given the increasing concerns related to pharmaceutical supply chain security, and in particular the threat of counterfeit, adulterated and diverted medicines, there are good grounds for reviewing the entire EU operation."

Jim Thomson, EAASM's chairman, said: "Dr Harper's report is written from a patient safety perspective and makes a number of recommendations to better secure the pharmaceutical supply. There is no doubt that some of these recommendations are key to increasing patient safety and should be actively considered by European legislators."

APIs from China and India also a factor
In a 2005 survey conducted by the Organisation for Economic Co-operation and Development (OECD) among pharmaceutical manufacturers, 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 ingredients.

In the survey, one company revealed it had detected counterfeit APIs originating in India in 33 countries, while another reported that counterfeits of its pharmaceutical products sourced in China were detected in 42 countries.

Professor Konstantin Keller, chairman of the Working Party on Legal Matters of the World Health Organisation's International Medical Products Anti-Counterfeiting Taskforce (IMPACT), said earlier this year: "When dealing with counterfeit drugs we are not only dealing with intellectual property, it directly impacts on the health of our citizens."

"There is now an urgent need to take care of the distribution channels and to ensure that these products can be safely distributed and arrive to the consumer in a safe manner. Improvements in legislation, customs and intellectual property still need to be made," concluded Keller.

30th September 2008

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